The Experts below are selected from a list of 85053 Experts worldwide ranked by ideXlab platform

Jennifer Rosenussbaumer - One of the best experts on this subject based on the ideXlab platform.

  • corneal light scatter after ultrathin descemet stripping automated endothelial keratoplasty versus descemet membrane endothelial keratoplasty in descemet endothelial thickness Comparison Trial a randomized controlled Trial
    Cornea, 2020
    Co-Authors: Kristin E Hirabayashi, Winston Chamberlain, Jennifer Rosenussbaumer, Ariana Austin, Laurel Stell, Charles P Lin
    Abstract:

    PURPOSE To compare the degree of corneal light scatter as measured by densitometry in ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK) in the Descemet endothelial thickness Comparison Trial. METHODS This was a prespecified secondary analysis of the Descemet endothelial thickness Comparison Trial, which was a prospective, randomized controlled Trial. Subjects with isolated endothelial dysfunction were enrolled and were randomized to either UT-DSAEK or DMEK. Corneal opacity was quantitatively measured by Pentacam densitometry (OCULUS) at 3, 6, and 12 months. RESULTS Fifty eyes of 38 patients were enrolled at the Casey Eye Institute at Oregon Health & Science University and the Byers Eye Institute at Stanford University. Corneal densitometry for the anterior and posterior layers improved in both UT-DSAEK and DMEK after surgery. The decrease was more pronounced in the posterior layer for both groups. However, there was no difference in the degree of corneal light scatter between UT-DSAEK and DMEK at postoperative month 12, and no difference in change in densitometry was observed between the 2 arms from baseline to month 12. CONCLUSIONS Both UT-DSAEK and DMEK experience an improvement in the degree of corneal light scatter after surgery. However, there was no difference in densitometry between the 2 groups at month 12. Therefore, other factors such as higher order aberrations in the posterior cornea rather than stromal-stromal interface haze mediate the superior visual outcomes in DMEK compared with UT-DSAEK.

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Michael J Ang, Winston Chamberlain, Ariana Austin, Charles P Lin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3;P  Conclusions and Relevance Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration ClinicalTrials.gov identifier:NCT02373137

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance: Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective: To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants: A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions: Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures: Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results: There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3; P < .001), and an 11.6-point improvement at 12 months compared with baseline (n = 26; 95% CI, 6.8-16.4; P < .001). Eyes randomized to DMEK had 0.9 points more improvement in NEI VFQ-39 composite score at 3 months compared with UT-DSAEK after controlling for baseline NEI VFQ-39 (95% CI, -6.2 to 8.0; P = .80). Conclusions and Relevance: Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration: ClinicalTrials.gov identifier: NCT02373137.

  • corneal higher order aberrations in descemet membrane endothelial keratoplasty versus ultrathin dsaek in the descemet endothelial thickness Comparison Trial a randomized clinical Trial
    Ophthalmology, 2019
    Co-Authors: Matthew J Duggan, Jennifer Rosenussbaumer, Ariana Austin, Charles P Lin, Paula C Labadzinzki, Winston Chamberlain
    Abstract:

    Purpose To compare corneal higher-order aberrations (HOA) after ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Design Patient- and outcome-masked randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were good candidates for DMEK or ultrathin DSAEK. Methods Corneal anterior and posterior surface HOA were measured with Scheimpflug imaging before surgery and at 3, 6, and 12 months after surgery. HOA after ultrathin DSAEK and DMEK were compared; correlation was performed between best spectacle-corrected visual acuity (BSCVA) and HOA at each time point. Main Outcome Measures Higher-order aberrations of the anterior and posterior cornea, expressed as the root mean square deviation from a best fit sphere reference surface. Results At 3, 6, and 12 months after surgery, the posterior corneal surface had significantly less coma (P ≤ 0.003) and total HOA (P ≤ 0.001) in DMEK compared with ultrathin DSAEK (4.0- and 6.0-mm OZ). Posterior trefoil (P ≤ 0.034), secondary astigmatism (P ≤ 0.042), and tetrafoil (P ≤ 0.045) were lower in DMEK than ultrathin DSAEK at 3, 6, or 12 months (either 4.0- or 6.0-mm OZ). There were no significant differences in anterior surface HOA between DMEK and ultrathin DSAEK at any post-surgical time. Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both). At 6 and 12 months, posterior corneal total HOA correlated with BSCVA (ρ ≤ 0.635, P ≤ 0.001; 4.0- and 6.0-mm OZ). There were no moderate or strong correlations between anterior or combined corneal surface HOA at any time point after surgery. Conclusions Descemet membrane endothelial keratoplasty results in less posterior corneal HOA compared with ultrathin DSAEK. Descemet membrane endothelial keratoplasty decreases and ultrathin DSAEK increases posterior corneal HOA compared with presurgical values. Total posterior corneal HOA correlates with 6- and 12-month postoperative visual acuity and may account for the better visual acuity observed after DMEK.

  • descemet endothelial thickness Comparison Trial a randomized Trial comparing ultrathin descemet stripping automated endothelial keratoplasty with descemet membrane endothelial keratoplasty
    Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Charles P Lin, Nicholas Schubach, Jameson Clover, Stephen D Mcleod, Travis C Porco, Thomas M Lietman, Jennifer Rosenussbaumer
    Abstract:

    Purpose To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction. Design Patient and outcome-masked, randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK. Methods Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery. Main Outcome Measures The primary outcome of the Trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry. Results A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P Conclusions Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.

Winston Chamberlain - One of the best experts on this subject based on the ideXlab platform.

  • corneal light scatter after ultrathin descemet stripping automated endothelial keratoplasty versus descemet membrane endothelial keratoplasty in descemet endothelial thickness Comparison Trial a randomized controlled Trial
    Cornea, 2020
    Co-Authors: Kristin E Hirabayashi, Winston Chamberlain, Jennifer Rosenussbaumer, Ariana Austin, Laurel Stell, Charles P Lin
    Abstract:

    PURPOSE To compare the degree of corneal light scatter as measured by densitometry in ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK) in the Descemet endothelial thickness Comparison Trial. METHODS This was a prespecified secondary analysis of the Descemet endothelial thickness Comparison Trial, which was a prospective, randomized controlled Trial. Subjects with isolated endothelial dysfunction were enrolled and were randomized to either UT-DSAEK or DMEK. Corneal opacity was quantitatively measured by Pentacam densitometry (OCULUS) at 3, 6, and 12 months. RESULTS Fifty eyes of 38 patients were enrolled at the Casey Eye Institute at Oregon Health & Science University and the Byers Eye Institute at Stanford University. Corneal densitometry for the anterior and posterior layers improved in both UT-DSAEK and DMEK after surgery. The decrease was more pronounced in the posterior layer for both groups. However, there was no difference in the degree of corneal light scatter between UT-DSAEK and DMEK at postoperative month 12, and no difference in change in densitometry was observed between the 2 arms from baseline to month 12. CONCLUSIONS Both UT-DSAEK and DMEK experience an improvement in the degree of corneal light scatter after surgery. However, there was no difference in densitometry between the 2 groups at month 12. Therefore, other factors such as higher order aberrations in the posterior cornea rather than stromal-stromal interface haze mediate the superior visual outcomes in DMEK compared with UT-DSAEK.

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Michael J Ang, Winston Chamberlain, Ariana Austin, Charles P Lin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3;P  Conclusions and Relevance Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration ClinicalTrials.gov identifier:NCT02373137

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance: Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective: To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants: A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions: Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures: Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results: There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3; P < .001), and an 11.6-point improvement at 12 months compared with baseline (n = 26; 95% CI, 6.8-16.4; P < .001). Eyes randomized to DMEK had 0.9 points more improvement in NEI VFQ-39 composite score at 3 months compared with UT-DSAEK after controlling for baseline NEI VFQ-39 (95% CI, -6.2 to 8.0; P = .80). Conclusions and Relevance: Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration: ClinicalTrials.gov identifier: NCT02373137.

  • corneal higher order aberrations in descemet membrane endothelial keratoplasty versus ultrathin dsaek in the descemet endothelial thickness Comparison Trial a randomized clinical Trial
    Ophthalmology, 2019
    Co-Authors: Matthew J Duggan, Jennifer Rosenussbaumer, Ariana Austin, Charles P Lin, Paula C Labadzinzki, Winston Chamberlain
    Abstract:

    Purpose To compare corneal higher-order aberrations (HOA) after ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Design Patient- and outcome-masked randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were good candidates for DMEK or ultrathin DSAEK. Methods Corneal anterior and posterior surface HOA were measured with Scheimpflug imaging before surgery and at 3, 6, and 12 months after surgery. HOA after ultrathin DSAEK and DMEK were compared; correlation was performed between best spectacle-corrected visual acuity (BSCVA) and HOA at each time point. Main Outcome Measures Higher-order aberrations of the anterior and posterior cornea, expressed as the root mean square deviation from a best fit sphere reference surface. Results At 3, 6, and 12 months after surgery, the posterior corneal surface had significantly less coma (P ≤ 0.003) and total HOA (P ≤ 0.001) in DMEK compared with ultrathin DSAEK (4.0- and 6.0-mm OZ). Posterior trefoil (P ≤ 0.034), secondary astigmatism (P ≤ 0.042), and tetrafoil (P ≤ 0.045) were lower in DMEK than ultrathin DSAEK at 3, 6, or 12 months (either 4.0- or 6.0-mm OZ). There were no significant differences in anterior surface HOA between DMEK and ultrathin DSAEK at any post-surgical time. Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both). At 6 and 12 months, posterior corneal total HOA correlated with BSCVA (ρ ≤ 0.635, P ≤ 0.001; 4.0- and 6.0-mm OZ). There were no moderate or strong correlations between anterior or combined corneal surface HOA at any time point after surgery. Conclusions Descemet membrane endothelial keratoplasty results in less posterior corneal HOA compared with ultrathin DSAEK. Descemet membrane endothelial keratoplasty decreases and ultrathin DSAEK increases posterior corneal HOA compared with presurgical values. Total posterior corneal HOA correlates with 6- and 12-month postoperative visual acuity and may account for the better visual acuity observed after DMEK.

  • descemet endothelial thickness Comparison Trial a randomized Trial comparing ultrathin descemet stripping automated endothelial keratoplasty with descemet membrane endothelial keratoplasty
    Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Charles P Lin, Nicholas Schubach, Jameson Clover, Stephen D Mcleod, Travis C Porco, Thomas M Lietman, Jennifer Rosenussbaumer
    Abstract:

    Purpose To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction. Design Patient and outcome-masked, randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK. Methods Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery. Main Outcome Measures The primary outcome of the Trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry. Results A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P Conclusions Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.

Charles P Lin - One of the best experts on this subject based on the ideXlab platform.

  • corneal light scatter after ultrathin descemet stripping automated endothelial keratoplasty versus descemet membrane endothelial keratoplasty in descemet endothelial thickness Comparison Trial a randomized controlled Trial
    Cornea, 2020
    Co-Authors: Kristin E Hirabayashi, Winston Chamberlain, Jennifer Rosenussbaumer, Ariana Austin, Laurel Stell, Charles P Lin
    Abstract:

    PURPOSE To compare the degree of corneal light scatter as measured by densitometry in ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK) in the Descemet endothelial thickness Comparison Trial. METHODS This was a prespecified secondary analysis of the Descemet endothelial thickness Comparison Trial, which was a prospective, randomized controlled Trial. Subjects with isolated endothelial dysfunction were enrolled and were randomized to either UT-DSAEK or DMEK. Corneal opacity was quantitatively measured by Pentacam densitometry (OCULUS) at 3, 6, and 12 months. RESULTS Fifty eyes of 38 patients were enrolled at the Casey Eye Institute at Oregon Health & Science University and the Byers Eye Institute at Stanford University. Corneal densitometry for the anterior and posterior layers improved in both UT-DSAEK and DMEK after surgery. The decrease was more pronounced in the posterior layer for both groups. However, there was no difference in the degree of corneal light scatter between UT-DSAEK and DMEK at postoperative month 12, and no difference in change in densitometry was observed between the 2 arms from baseline to month 12. CONCLUSIONS Both UT-DSAEK and DMEK experience an improvement in the degree of corneal light scatter after surgery. However, there was no difference in densitometry between the 2 groups at month 12. Therefore, other factors such as higher order aberrations in the posterior cornea rather than stromal-stromal interface haze mediate the superior visual outcomes in DMEK compared with UT-DSAEK.

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Michael J Ang, Winston Chamberlain, Ariana Austin, Charles P Lin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3;P  Conclusions and Relevance Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration ClinicalTrials.gov identifier:NCT02373137

  • corneal higher order aberrations in descemet membrane endothelial keratoplasty versus ultrathin dsaek in the descemet endothelial thickness Comparison Trial a randomized clinical Trial
    Ophthalmology, 2019
    Co-Authors: Matthew J Duggan, Jennifer Rosenussbaumer, Ariana Austin, Charles P Lin, Paula C Labadzinzki, Winston Chamberlain
    Abstract:

    Purpose To compare corneal higher-order aberrations (HOA) after ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Design Patient- and outcome-masked randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were good candidates for DMEK or ultrathin DSAEK. Methods Corneal anterior and posterior surface HOA were measured with Scheimpflug imaging before surgery and at 3, 6, and 12 months after surgery. HOA after ultrathin DSAEK and DMEK were compared; correlation was performed between best spectacle-corrected visual acuity (BSCVA) and HOA at each time point. Main Outcome Measures Higher-order aberrations of the anterior and posterior cornea, expressed as the root mean square deviation from a best fit sphere reference surface. Results At 3, 6, and 12 months after surgery, the posterior corneal surface had significantly less coma (P ≤ 0.003) and total HOA (P ≤ 0.001) in DMEK compared with ultrathin DSAEK (4.0- and 6.0-mm OZ). Posterior trefoil (P ≤ 0.034), secondary astigmatism (P ≤ 0.042), and tetrafoil (P ≤ 0.045) were lower in DMEK than ultrathin DSAEK at 3, 6, or 12 months (either 4.0- or 6.0-mm OZ). There were no significant differences in anterior surface HOA between DMEK and ultrathin DSAEK at any post-surgical time. Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both). At 6 and 12 months, posterior corneal total HOA correlated with BSCVA (ρ ≤ 0.635, P ≤ 0.001; 4.0- and 6.0-mm OZ). There were no moderate or strong correlations between anterior or combined corneal surface HOA at any time point after surgery. Conclusions Descemet membrane endothelial keratoplasty results in less posterior corneal HOA compared with ultrathin DSAEK. Descemet membrane endothelial keratoplasty decreases and ultrathin DSAEK increases posterior corneal HOA compared with presurgical values. Total posterior corneal HOA correlates with 6- and 12-month postoperative visual acuity and may account for the better visual acuity observed after DMEK.

  • descemet endothelial thickness Comparison Trial a randomized Trial comparing ultrathin descemet stripping automated endothelial keratoplasty with descemet membrane endothelial keratoplasty
    Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Charles P Lin, Nicholas Schubach, Jameson Clover, Stephen D Mcleod, Travis C Porco, Thomas M Lietman, Jennifer Rosenussbaumer
    Abstract:

    Purpose To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction. Design Patient and outcome-masked, randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK. Methods Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery. Main Outcome Measures The primary outcome of the Trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry. Results A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P Conclusions Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.

Ariana Austin - One of the best experts on this subject based on the ideXlab platform.

  • corneal light scatter after ultrathin descemet stripping automated endothelial keratoplasty versus descemet membrane endothelial keratoplasty in descemet endothelial thickness Comparison Trial a randomized controlled Trial
    Cornea, 2020
    Co-Authors: Kristin E Hirabayashi, Winston Chamberlain, Jennifer Rosenussbaumer, Ariana Austin, Laurel Stell, Charles P Lin
    Abstract:

    PURPOSE To compare the degree of corneal light scatter as measured by densitometry in ultrathin Descemet Stripping Automated Endothelial Keratoplasty (UT-DSAEK) and Descemet Membrane Endothelial Keratoplasty (DMEK) in the Descemet endothelial thickness Comparison Trial. METHODS This was a prespecified secondary analysis of the Descemet endothelial thickness Comparison Trial, which was a prospective, randomized controlled Trial. Subjects with isolated endothelial dysfunction were enrolled and were randomized to either UT-DSAEK or DMEK. Corneal opacity was quantitatively measured by Pentacam densitometry (OCULUS) at 3, 6, and 12 months. RESULTS Fifty eyes of 38 patients were enrolled at the Casey Eye Institute at Oregon Health & Science University and the Byers Eye Institute at Stanford University. Corneal densitometry for the anterior and posterior layers improved in both UT-DSAEK and DMEK after surgery. The decrease was more pronounced in the posterior layer for both groups. However, there was no difference in the degree of corneal light scatter between UT-DSAEK and DMEK at postoperative month 12, and no difference in change in densitometry was observed between the 2 arms from baseline to month 12. CONCLUSIONS Both UT-DSAEK and DMEK experience an improvement in the degree of corneal light scatter after surgery. However, there was no difference in densitometry between the 2 groups at month 12. Therefore, other factors such as higher order aberrations in the posterior cornea rather than stromal-stromal interface haze mediate the superior visual outcomes in DMEK compared with UT-DSAEK.

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Michael J Ang, Winston Chamberlain, Ariana Austin, Charles P Lin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3;P  Conclusions and Relevance Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration ClinicalTrials.gov identifier:NCT02373137

  • effect of unilateral endothelial keratoplasty on vision related quality of life outcomes in the descemet endothelial thickness Comparison Trial detect a secondary analysis of a randomized clinical Trial
    JAMA Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Julia Pickel, Jennifer Rosenussbaumer
    Abstract:

    Importance: Vision-related quality of life can be a valuable outcome for some interventions in ophthalmology. In the primary Descemet Endothelial Thickness Comparison Trial (DETECT), Descemet membrane endothelial keratoplasty (DMEK) had superior postoperative visual acuity compared with ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK). It is of interest to determine whether this trend extends to quality of life. Objective: To determine the effect of UT-DSAEK and DMEK on vision-related quality of life. Design, Setting, and Participants: A prespecified secondary analysis of a 2-surgeon patient- and outcome-masked randomized clinical Trial was conducted at the Casey Eye Institute in Portland, Oregon, and Byers Eye Institute in Palo Alto, California. The study was conducted between January 20, 2015, and April 26, 2017. DETECT enrolled 38 individuals and included 50 eyes with isolated endothelial dysfunction; for this analysis, the second eye from a single participant was excluded along with any questionnaires in the first eye after second eye surgery for evaluation of 38 eyes at baseline and 3 months and 26 eyes at 12 months. Mean (SD) baseline visual acuity was 0.35 (0.31) logMAR in the DMEK arm and 0.28 (0.22) logMAR in the UT-DSAEK arm. Each arm consisted of 19 participants: 18 individuals with Fuchs dystrophy and 1 participant with pseudophakic bullous keratopathy. Interventions: Study eyes were randomized to receive either UT-DSAEK or DMEK. Main Outcomes and Measures: Responses to the National Eye Institute (NEI) Visual Function Questionnaire-39 (VFQ-39) administered at baseline and 3 and 12 months postoperatively were analyzed using the NEI-defined traditional subscales and composite score on a 100-point scale and with a Rasch-refined analysis. Results: There were more women in both arms of the study (UT-DSAEK, 12 [63%]; DMEK, 11 [58%]); mean (SD) age was 68 (11) years in the UT-DSAEK arm and 68 (4) years in the DMEK arm. Overall, study participants experienced a 9.1-point improvement in NEI VFQ-39 composite score at 3 months compared with baseline (N = 38; 95% CI, 4.9-13.3; P < .001), and an 11.6-point improvement at 12 months compared with baseline (n = 26; 95% CI, 6.8-16.4; P < .001). Eyes randomized to DMEK had 0.9 points more improvement in NEI VFQ-39 composite score at 3 months compared with UT-DSAEK after controlling for baseline NEI VFQ-39 (95% CI, -6.2 to 8.0; P = .80). Conclusions and Relevance: Improvement in vision-related quality of life was not shown to be greater with DMEK compared with UT-DSAEK. Trial Registration: ClinicalTrials.gov identifier: NCT02373137.

  • corneal higher order aberrations in descemet membrane endothelial keratoplasty versus ultrathin dsaek in the descemet endothelial thickness Comparison Trial a randomized clinical Trial
    Ophthalmology, 2019
    Co-Authors: Matthew J Duggan, Jennifer Rosenussbaumer, Ariana Austin, Charles P Lin, Paula C Labadzinzki, Winston Chamberlain
    Abstract:

    Purpose To compare corneal higher-order aberrations (HOA) after ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). Design Patient- and outcome-masked randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were good candidates for DMEK or ultrathin DSAEK. Methods Corneal anterior and posterior surface HOA were measured with Scheimpflug imaging before surgery and at 3, 6, and 12 months after surgery. HOA after ultrathin DSAEK and DMEK were compared; correlation was performed between best spectacle-corrected visual acuity (BSCVA) and HOA at each time point. Main Outcome Measures Higher-order aberrations of the anterior and posterior cornea, expressed as the root mean square deviation from a best fit sphere reference surface. Results At 3, 6, and 12 months after surgery, the posterior corneal surface had significantly less coma (P ≤ 0.003) and total HOA (P ≤ 0.001) in DMEK compared with ultrathin DSAEK (4.0- and 6.0-mm OZ). Posterior trefoil (P ≤ 0.034), secondary astigmatism (P ≤ 0.042), and tetrafoil (P ≤ 0.045) were lower in DMEK than ultrathin DSAEK at 3, 6, or 12 months (either 4.0- or 6.0-mm OZ). There were no significant differences in anterior surface HOA between DMEK and ultrathin DSAEK at any post-surgical time. Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both). At 6 and 12 months, posterior corneal total HOA correlated with BSCVA (ρ ≤ 0.635, P ≤ 0.001; 4.0- and 6.0-mm OZ). There were no moderate or strong correlations between anterior or combined corneal surface HOA at any time point after surgery. Conclusions Descemet membrane endothelial keratoplasty results in less posterior corneal HOA compared with ultrathin DSAEK. Descemet membrane endothelial keratoplasty decreases and ultrathin DSAEK increases posterior corneal HOA compared with presurgical values. Total posterior corneal HOA correlates with 6- and 12-month postoperative visual acuity and may account for the better visual acuity observed after DMEK.

  • descemet endothelial thickness Comparison Trial a randomized Trial comparing ultrathin descemet stripping automated endothelial keratoplasty with descemet membrane endothelial keratoplasty
    Ophthalmology, 2019
    Co-Authors: Winston Chamberlain, Ariana Austin, Charles P Lin, Nicholas Schubach, Jameson Clover, Stephen D Mcleod, Travis C Porco, Thomas M Lietman, Jennifer Rosenussbaumer
    Abstract:

    Purpose To compare clinical outcomes of ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) in the treatment of corneal endothelial dysfunction. Design Patient and outcome-masked, randomized controlled clinical Trial. Participants Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were considered good candidates for DMEK or UT-DSAEK. Methods Study eyes were randomized by the eye bank to UT-DSAEK or DMEK 1 to 2 days before surgery. Main Outcome Measures The primary outcome of the Trial was best spectacle-corrected visual acuity (BSCVA) at 6 months. Secondary outcomes included 3- and 12-month BSCVA; 3-, 6-, and 12-month endothelial cell counts; intraoperative and postoperative complications; and change in pachymetry. Results A total of 216 patients with endothelial dysfunction were screened, and 50 eyes of 38 patients were enrolled by 2 surgeons at Casey Eye Institute at Oregon Health & Science University in Portland, Oregon, and at Byers Eye Institute at Stanford University in Palo Alto, California. Overall, we found DMEK to have better visual acuity outcomes compared with UT-DSAEK after correcting for baseline visual acuity: compared with UT-DSAEK, those randomized to DMEK had 1.5 lines better BSCVA at 3 months (95% confidence interval [CI], 2.5–0.6 lines better; P = 0.002), 1.8 lines better BSCVA at 6 months (95% CI, 2.8–1.0 lines better; P Conclusions Descemet membrane endothelial keratoplasty had superior visual acuity results compared with UT-DSAEK at 3, 6, and 12 months in patients with isolated endothelial dysfunction with similar complication rates.

Hong Jin Jeon - One of the best experts on this subject based on the ideXlab platform.

  • efficacy of ziprasidone monotherapy in patients with anxious depression a 12 week randomized double blind placebo controlled sequential parallel Comparison Trial
    Journal of Psychiatric Research, 2015
    Co-Authors: Jungyoon Heo, David Mischoulon, Hong Jin Jeon, Maurizio Fava, Lee Baer, Alisabet Clain, James Doorley, Angela Pisoni
    Abstract:

    Abstract Anxious depression, defined as major depressive disorder (MDD) accompanied by high levels of anxiety, seems to be difficult to treat with traditional antidepressant monotherapy. The purpose of this study was to assess the efficacy of ziprasidone monotherapy in patients with anxious depression versus non-anxious depression. One hundred and twenty outpatients were enrolled in a 12-week study that was divided into two 6-week periods according to the sequential parallel Comparison design. Patients were randomized in a 2:3:3 multi-ratio to receive ziprasidone for 12 weeks, placebo for 6 weeks, followed by ziprasidone for 6 weeks, or placebo for 12 weeks. Efficacy was measured according to the 17-item Hamilton Depression Rating Scale (HRDS-17), Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-SR). Anxious depression was defined as a score of ≥7 on the HDRS-17 anxiety/somatization subscale. In phase I and II, ziprasidone monotherapy led to no significant changes compared with placebo on the HDRS-17 and QIDS-SR scores in patients with both anxious and non-anxious depression. In the pooled analysis, ziprasidone monotherapy also produced no significance on the HDRS-17 (Z = 0.25, P = 0.80) and QIDS-SR (Z = 0.43, P = 0.67) in patients with anxious depression. In conclusion, treatment with ziprasidone monotherapy may produce no significant improvement compared with placebo in patients with in anxious depression. Trial registration ClinicalTrials.gov identifier: NCT00555997 .

  • psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in patients with major depressive disorder a 12 week randomized double blind placebo controlled sequential parallel Comparison Trial
    International Clinical Psychopharmacology, 2014
    Co-Authors: Hong Jin Jeon, David Mischoulon, Maurizio Fava, Lee Baer, Alisabet Clain, James Doorley, Moneika Dipierro, Amber Cardoos, George I Papakostas
    Abstract:

    The aim of this study was to evaluate efficacy of ziprasidone monotherapy for major depressive disorder (MDD) with and without psychomotor symptoms. In accordance with the sequential parallel Comparison design, 106 MDD patients (age 44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was carried out on 12-week double-blind treatment with either ziprasidone (40-160 mg/day) or placebo, divided into two phases of 6 weeks each to the assigned treatment sequences, drug/drug, placebo/placebo, and placebo/drug. Psychomotor symptoms were evaluated on the basis of the Mini-International Neuropsychiatric Interview at baseline. Efficacy assessments, on the basis of the 17-item Hamilton Depression Rating Scale (HDRS-17) and the Quick Inventory of Depressive Symptomatology Scale, Self-Rated (QIDS-SR), were performed every week throughout the Trial. In phase I, ziprasidone monotherapy produced significant improvement in patients with psychomotor symptoms compared with placebo on the basis of HDRS-17 (F=5.95, P=0.017) and QIDS-SR (F=5.26, P=0.025) scores, whereas no significant changes were found in HDRS-17 (F=2.32, P=0.15) and QIDS-SR (F=3.70, P=0.074) scores in patients without psychomotor symptoms. In phase II, ziprasidone monotherapy produced no significant differences compared with placebo. In the pooled analysis, ziprasidone monotherapy showed significance according to QIDS-SR (Z=2.00, P=0.046) and a trend toward statistical significance according to the HDRS-17 (Z=1.66, P=0.10) in patients with psychomotor symptoms. Ziprasidone monotherapy may produce significant improvement compared with placebo in MDD patients with psychomotor symptoms.