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Prajna Lalitha - One of the best experts on this subject based on the ideXlab platform.
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In Vitro Comparison of the Acanthamoeba Cysticidal Activity of Povidone Iodine, Natamycin, and Chlorhexidine
'Elsevier BV', 2021Co-Authors: Travis Redd, Md K. Mph, Prajna Lalitha, Thomas M Lietman, Maya Talbott Mhs, Mt ,vicky Cevallos, Gerami D. Seitzman, Jeremy Keenan, Md D. MphAbstract:Purpose: Acanthamoeba keratitis often is refractory to medical and surgical therapy, primarily because of the remarkable resilience of Acanthamoeba cysts. In this study, we directly compared the cysticidal activity and potency of several candidate medical therapies in vitro. Design: Experimental study. Participants: In vitro Acanthamoeba specimens obtained from 9 patients with keratitis seen at the Francis I. Proctor Foundation from 2008 through 2012. Methods: The minimum cysticidal concentration (MCC) of povidone iodine, Natamycin, and chlorhexidine was investigated using an established assay technique. The relative potency of each agent was estimated starting with concentrations commonly used in clinical practice and determining the number of two-fold dilutions required to reach the MCC. Statistical comparisons of relative potency were performed using bootstrap simulations and permutation tests. Main Outcome Measures: Minimum cysticidal concentration and the number of two-fold dilutions required to reach the MCC. Results: The MCC for chlorhexidine ranged from 3.1 to 25 μg/ml (median, 12.5 μg/ml; interquartile range [IQR], 6.25–12.5 μg/ml), the MCC for Natamycin ranged from 390.6 to 3125 μg/ml (median, 390.6 μg/ml; IQR, 390.6–781.2 μg/ml), and the MCC for povidone iodine ranged from 0.3 to 78.1 μg/ml (median, 2.4 μg/ml; IQR, 0.6–9.8 μg/ml). Doses commonly used in clinical practice (povidone iodine 1%, Natamycin 5%, and chlorhexidine 0.04%) were approximately 12, 7, and 5 two-fold dilutions higher than the drug’s corresponding median MCC, respectively (P < 0.001, comparing 3 drugs). Povidone iodine 1% had the highest potency of the 3 medications tested, requiring more dilutions than Natamycin 5% (P < 0.001) and chlorhexidine 0.04% (P < 0.001) to reach the MCC. Conclusions: All 3 medications demonstrated in vitro cysticidal activity in each of the 9 isolates. The potency of 1% povidone iodine was greater than standard formulations of Natamycin or chlorhexidine. Although its clinical efficacy is yet to be determined, povidone iodine may be considered as a potential adjuvant treatment in cases of recalcitrant Acanthamoeba keratitis
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cross linking assisted infection reduction a randomized clinical trial evaluating the effect of adjuvant cross linking on outcomes in fungal keratitis
Ophthalmology, 2020Co-Authors: Venkatesh N Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Purpose To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2×2 factorial design, randomized controlled clinical trial. Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Methods Study eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical Natamycin 5% alone, (2) topical Natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57–3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to Natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47–2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, −0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03–0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.
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cross linking assisted infection reduction clair a randomized clinical trial evaluating the effect of adjuvant cross linking on microbiological and clinical outcomes in fungal keratitis
Ophthalmology, 2019Co-Authors: Namperumalsamy Venkatesh Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Abstract Objective To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2 x 2 factorial design, randomized controlled clinical trial ; Study Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Intervention Study eyes were randomized to one of four treatment combinations using an adaptive randomization protocol. The treatment arms included: 1. Topical Natamycin 5% alone, 2. Topical Natamycin 5% plus CXL, 3. Topical amphotericin B 0.15% alone, and 4. Topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity (BSCVA) at 3 weeks and 3 months, % of study participants with epithelial healing at 3 days, 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity although this was not statistically significant (95% CI 0.57 to 3.06; P=0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin compared with Natamycin when evaluating as a group regardless of whether or not they received CXL (coef 1.10, 95% CI 0.47 to 2.54; P=0.84). BSCVA was approximately 0.22 logMAR (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI -0.04 to 0.40, P=0.04) and 0.32-logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI 0.03 to 0.54; P=0.02). There was no difference in infiltrate and/or scar size, % epithelialized or adverse events when comparing CXL versus no CXL or the two topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers and it may result in decreased visual acuity.
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association between in vitro susceptibility to Natamycin and voriconazole and clinical outcomes in fungal keratitis
Ophthalmology, 2014Co-Authors: Prajna Lalitha, Venkatesh N Prajna, Rajarathinam Karpagam, Manoharan Geetha, Kieran S Obrien, Stephen D Mcleod, Nisha R Acharya, Catherine E Oldenburg, Thomas M LietmanAbstract:Purpose To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial. Design Experimental study using data from a randomized comparative trial. Participants Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis. Methods The Mycotic Ulcer Treatment Trial I was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical Natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to Natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed. Main Outcome Measures The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate or scar size; corneal perforation and/or therapeutic penetrating keratoplasty; and time to re-epithelialization. Results A 2-fold increase in MIC was associated with a larger 3-month infiltrate or scar size (0.21 mm; 95% confidence interval [CI], 0.10–0.31; P P = 0.02). No correlation was found between MIC and 3-month visual acuity. For Natamycin-treated cases, an association was found between higher Natamycin MIC with larger 3-month infiltrate or scar size (0.29 mm; 95% CI, 0.15–0.43; P P Conclusions Decreased susceptibility to Natamycin was associated with increased infiltrate or scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome.
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in vitro susceptibility of filamentous fungal isolates from a corneal ulcer clinical trial
American Journal of Ophthalmology, 2014Co-Authors: Prajna Lalitha, Catherine Q Sun, Venkatesh N Prajna, Rajarathinam Karpagam, Manoharan Geetha, Kieran S Obrien, Vicky Cevallos, Stephen D Mcleod, Nisha R Acharya, Thomas M LietmanAbstract:Purpose To describe the minimum inhibitory concentration (MIC) of fungal isolates to Natamycin and voriconazole, and to compare these MICs to previous ocular susceptibility studies. Design Experimental laboratory study using isolates from a randomized clinical trial. Methods The Mycotic Ulcer Treatment Trial I was a randomized, double-masked, multicenter trial comparing topical Natamycin and voriconazole for fungal keratitis treatment. Susceptibility testing to Natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute methods. The relationship between organism and MIC was assessed. A literature review was performed to compare results to previous ocular susceptibility studies. Results Of the 323 patients enrolled in the trial, MICs were available for 221 (68%). Fusarium (n = 126) and Aspergillus species (n = 52) were the most commonly isolated organisms. MICs to Natamycin and voriconazole were significantly different across all genera ( P 50 ) and 90th percentile (MIC 90 ) for Natamycin were equal to or higher than voriconazole for all organisms except Curvularia species. Compared to other organisms, Fusarium species isolates had the highest MICs to voriconazole and Aspergillus flavus isolates had the highest MICs to Natamycin. Our results were similar to previous reports except that the voriconazole MIC 90 against Aspergillus species was 2-fold higher and the Natamycin MIC 90 against Aspergillus fumigatus was 4-fold higher in our study. Conclusion In this large susceptibility study, Fusarium isolates were least susceptible to voriconazole and A flavus isolates were least susceptible to Natamycin when compared to other filamentous fungi. In the future, susceptibility testing may help guide therapy if performed in a timely manner.
Thomas M Lietman - One of the best experts on this subject based on the ideXlab platform.
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In Vitro Comparison of the Acanthamoeba Cysticidal Activity of Povidone Iodine, Natamycin, and Chlorhexidine
'Elsevier BV', 2021Co-Authors: Travis Redd, Md K. Mph, Prajna Lalitha, Thomas M Lietman, Maya Talbott Mhs, Mt ,vicky Cevallos, Gerami D. Seitzman, Jeremy Keenan, Md D. MphAbstract:Purpose: Acanthamoeba keratitis often is refractory to medical and surgical therapy, primarily because of the remarkable resilience of Acanthamoeba cysts. In this study, we directly compared the cysticidal activity and potency of several candidate medical therapies in vitro. Design: Experimental study. Participants: In vitro Acanthamoeba specimens obtained from 9 patients with keratitis seen at the Francis I. Proctor Foundation from 2008 through 2012. Methods: The minimum cysticidal concentration (MCC) of povidone iodine, Natamycin, and chlorhexidine was investigated using an established assay technique. The relative potency of each agent was estimated starting with concentrations commonly used in clinical practice and determining the number of two-fold dilutions required to reach the MCC. Statistical comparisons of relative potency were performed using bootstrap simulations and permutation tests. Main Outcome Measures: Minimum cysticidal concentration and the number of two-fold dilutions required to reach the MCC. Results: The MCC for chlorhexidine ranged from 3.1 to 25 μg/ml (median, 12.5 μg/ml; interquartile range [IQR], 6.25–12.5 μg/ml), the MCC for Natamycin ranged from 390.6 to 3125 μg/ml (median, 390.6 μg/ml; IQR, 390.6–781.2 μg/ml), and the MCC for povidone iodine ranged from 0.3 to 78.1 μg/ml (median, 2.4 μg/ml; IQR, 0.6–9.8 μg/ml). Doses commonly used in clinical practice (povidone iodine 1%, Natamycin 5%, and chlorhexidine 0.04%) were approximately 12, 7, and 5 two-fold dilutions higher than the drug’s corresponding median MCC, respectively (P < 0.001, comparing 3 drugs). Povidone iodine 1% had the highest potency of the 3 medications tested, requiring more dilutions than Natamycin 5% (P < 0.001) and chlorhexidine 0.04% (P < 0.001) to reach the MCC. Conclusions: All 3 medications demonstrated in vitro cysticidal activity in each of the 9 isolates. The potency of 1% povidone iodine was greater than standard formulations of Natamycin or chlorhexidine. Although its clinical efficacy is yet to be determined, povidone iodine may be considered as a potential adjuvant treatment in cases of recalcitrant Acanthamoeba keratitis
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cross linking assisted infection reduction a randomized clinical trial evaluating the effect of adjuvant cross linking on outcomes in fungal keratitis
Ophthalmology, 2020Co-Authors: Venkatesh N Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Purpose To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2×2 factorial design, randomized controlled clinical trial. Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Methods Study eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical Natamycin 5% alone, (2) topical Natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57–3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to Natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47–2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, −0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03–0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.
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cross linking assisted infection reduction clair a randomized clinical trial evaluating the effect of adjuvant cross linking on microbiological and clinical outcomes in fungal keratitis
Ophthalmology, 2019Co-Authors: Namperumalsamy Venkatesh Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Abstract Objective To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2 x 2 factorial design, randomized controlled clinical trial ; Study Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Intervention Study eyes were randomized to one of four treatment combinations using an adaptive randomization protocol. The treatment arms included: 1. Topical Natamycin 5% alone, 2. Topical Natamycin 5% plus CXL, 3. Topical amphotericin B 0.15% alone, and 4. Topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity (BSCVA) at 3 weeks and 3 months, % of study participants with epithelial healing at 3 days, 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity although this was not statistically significant (95% CI 0.57 to 3.06; P=0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin compared with Natamycin when evaluating as a group regardless of whether or not they received CXL (coef 1.10, 95% CI 0.47 to 2.54; P=0.84). BSCVA was approximately 0.22 logMAR (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI -0.04 to 0.40, P=0.04) and 0.32-logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI 0.03 to 0.54; P=0.02). There was no difference in infiltrate and/or scar size, % epithelialized or adverse events when comparing CXL versus no CXL or the two topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers and it may result in decreased visual acuity.
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association between in vitro susceptibility to Natamycin and voriconazole and clinical outcomes in fungal keratitis
Ophthalmology, 2014Co-Authors: Prajna Lalitha, Venkatesh N Prajna, Rajarathinam Karpagam, Manoharan Geetha, Kieran S Obrien, Stephen D Mcleod, Nisha R Acharya, Catherine E Oldenburg, Thomas M LietmanAbstract:Purpose To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial. Design Experimental study using data from a randomized comparative trial. Participants Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis. Methods The Mycotic Ulcer Treatment Trial I was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical Natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to Natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed. Main Outcome Measures The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate or scar size; corneal perforation and/or therapeutic penetrating keratoplasty; and time to re-epithelialization. Results A 2-fold increase in MIC was associated with a larger 3-month infiltrate or scar size (0.21 mm; 95% confidence interval [CI], 0.10–0.31; P P = 0.02). No correlation was found between MIC and 3-month visual acuity. For Natamycin-treated cases, an association was found between higher Natamycin MIC with larger 3-month infiltrate or scar size (0.29 mm; 95% CI, 0.15–0.43; P P Conclusions Decreased susceptibility to Natamycin was associated with increased infiltrate or scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome.
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in vitro susceptibility of filamentous fungal isolates from a corneal ulcer clinical trial
American Journal of Ophthalmology, 2014Co-Authors: Prajna Lalitha, Catherine Q Sun, Venkatesh N Prajna, Rajarathinam Karpagam, Manoharan Geetha, Kieran S Obrien, Vicky Cevallos, Stephen D Mcleod, Nisha R Acharya, Thomas M LietmanAbstract:Purpose To describe the minimum inhibitory concentration (MIC) of fungal isolates to Natamycin and voriconazole, and to compare these MICs to previous ocular susceptibility studies. Design Experimental laboratory study using isolates from a randomized clinical trial. Methods The Mycotic Ulcer Treatment Trial I was a randomized, double-masked, multicenter trial comparing topical Natamycin and voriconazole for fungal keratitis treatment. Susceptibility testing to Natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute methods. The relationship between organism and MIC was assessed. A literature review was performed to compare results to previous ocular susceptibility studies. Results Of the 323 patients enrolled in the trial, MICs were available for 221 (68%). Fusarium (n = 126) and Aspergillus species (n = 52) were the most commonly isolated organisms. MICs to Natamycin and voriconazole were significantly different across all genera ( P 50 ) and 90th percentile (MIC 90 ) for Natamycin were equal to or higher than voriconazole for all organisms except Curvularia species. Compared to other organisms, Fusarium species isolates had the highest MICs to voriconazole and Aspergillus flavus isolates had the highest MICs to Natamycin. Our results were similar to previous reports except that the voriconazole MIC 90 against Aspergillus species was 2-fold higher and the Natamycin MIC 90 against Aspergillus fumigatus was 4-fold higher in our study. Conclusion In this large susceptibility study, Fusarium isolates were least susceptible to voriconazole and A flavus isolates were least susceptible to Natamycin when compared to other filamentous fungi. In the future, susceptibility testing may help guide therapy if performed in a timely manner.
Jennifer Rosenussbaumer - One of the best experts on this subject based on the ideXlab platform.
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cross linking assisted infection reduction a randomized clinical trial evaluating the effect of adjuvant cross linking on outcomes in fungal keratitis
Ophthalmology, 2020Co-Authors: Venkatesh N Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Purpose To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2×2 factorial design, randomized controlled clinical trial. Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Methods Study eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical Natamycin 5% alone, (2) topical Natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57–3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to Natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47–2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, −0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03–0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.
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cross linking assisted infection reduction clair a randomized clinical trial evaluating the effect of adjuvant cross linking on microbiological and clinical outcomes in fungal keratitis
Ophthalmology, 2019Co-Authors: Namperumalsamy Venkatesh Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Abstract Objective To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2 x 2 factorial design, randomized controlled clinical trial ; Study Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Intervention Study eyes were randomized to one of four treatment combinations using an adaptive randomization protocol. The treatment arms included: 1. Topical Natamycin 5% alone, 2. Topical Natamycin 5% plus CXL, 3. Topical amphotericin B 0.15% alone, and 4. Topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity (BSCVA) at 3 weeks and 3 months, % of study participants with epithelial healing at 3 days, 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity although this was not statistically significant (95% CI 0.57 to 3.06; P=0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin compared with Natamycin when evaluating as a group regardless of whether or not they received CXL (coef 1.10, 95% CI 0.47 to 2.54; P=0.84). BSCVA was approximately 0.22 logMAR (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI -0.04 to 0.40, P=0.04) and 0.32-logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI 0.03 to 0.54; P=0.02). There was no difference in infiltrate and/or scar size, % epithelialized or adverse events when comparing CXL versus no CXL or the two topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers and it may result in decreased visual acuity.
Venkatesh N Prajna - One of the best experts on this subject based on the ideXlab platform.
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cross linking assisted infection reduction a randomized clinical trial evaluating the effect of adjuvant cross linking on outcomes in fungal keratitis
Ophthalmology, 2020Co-Authors: Venkatesh N Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Purpose To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2×2 factorial design, randomized controlled clinical trial. Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Methods Study eyes were randomized to 1 of 4 treatment combinations using an adaptive randomization protocol. The treatment arms included (1) topical Natamycin 5% alone, (2) topical Natamycin 5% plus CXL, (3) topical amphotericin B 0.15% alone, and (4) topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle-corrected visual acuity (BSCVA) at 3 weeks and 3 months, percentage of study participants with epithelial healing at 3 days, 3 weeks, and 3 months, infiltrate or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity, although this was not statistically significant (95% confidence interval [CI], 0.57–3.06; P = 0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin and those randomized to Natamycin when evaluating as a group regardless of whether or not they received CXL (coefficient 1.10; 95% CI, 0.47–2.54; P = 0.84). The BSCVA was approximately 0.22 logarithm of the minimum angle of resolution (logMAR) (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI, −0.04 to 0.40; P = 0.04) and 0.32 logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI, 0.03–0.54; P = 0.02). There was no difference in infiltrate or scar size, percentage of epithelialized or adverse events when comparing CXL with no CXL or the 2 topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers, and it may result in decreased visual acuity.
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association between in vitro susceptibility to Natamycin and voriconazole and clinical outcomes in fungal keratitis
Ophthalmology, 2014Co-Authors: Prajna Lalitha, Venkatesh N Prajna, Rajarathinam Karpagam, Manoharan Geetha, Kieran S Obrien, Stephen D Mcleod, Nisha R Acharya, Catherine E Oldenburg, Thomas M LietmanAbstract:Purpose To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial. Design Experimental study using data from a randomized comparative trial. Participants Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis. Methods The Mycotic Ulcer Treatment Trial I was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical Natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to Natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed. Main Outcome Measures The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate or scar size; corneal perforation and/or therapeutic penetrating keratoplasty; and time to re-epithelialization. Results A 2-fold increase in MIC was associated with a larger 3-month infiltrate or scar size (0.21 mm; 95% confidence interval [CI], 0.10–0.31; P P = 0.02). No correlation was found between MIC and 3-month visual acuity. For Natamycin-treated cases, an association was found between higher Natamycin MIC with larger 3-month infiltrate or scar size (0.29 mm; 95% CI, 0.15–0.43; P P Conclusions Decreased susceptibility to Natamycin was associated with increased infiltrate or scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome.
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in vitro susceptibility of filamentous fungal isolates from a corneal ulcer clinical trial
American Journal of Ophthalmology, 2014Co-Authors: Prajna Lalitha, Catherine Q Sun, Venkatesh N Prajna, Rajarathinam Karpagam, Manoharan Geetha, Kieran S Obrien, Vicky Cevallos, Stephen D Mcleod, Nisha R Acharya, Thomas M LietmanAbstract:Purpose To describe the minimum inhibitory concentration (MIC) of fungal isolates to Natamycin and voriconazole, and to compare these MICs to previous ocular susceptibility studies. Design Experimental laboratory study using isolates from a randomized clinical trial. Methods The Mycotic Ulcer Treatment Trial I was a randomized, double-masked, multicenter trial comparing topical Natamycin and voriconazole for fungal keratitis treatment. Susceptibility testing to Natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute methods. The relationship between organism and MIC was assessed. A literature review was performed to compare results to previous ocular susceptibility studies. Results Of the 323 patients enrolled in the trial, MICs were available for 221 (68%). Fusarium (n = 126) and Aspergillus species (n = 52) were the most commonly isolated organisms. MICs to Natamycin and voriconazole were significantly different across all genera ( P 50 ) and 90th percentile (MIC 90 ) for Natamycin were equal to or higher than voriconazole for all organisms except Curvularia species. Compared to other organisms, Fusarium species isolates had the highest MICs to voriconazole and Aspergillus flavus isolates had the highest MICs to Natamycin. Our results were similar to previous reports except that the voriconazole MIC 90 against Aspergillus species was 2-fold higher and the Natamycin MIC 90 against Aspergillus fumigatus was 4-fold higher in our study. Conclusion In this large susceptibility study, Fusarium isolates were least susceptible to voriconazole and A flavus isolates were least susceptible to Natamycin when compared to other filamentous fungi. In the future, susceptibility testing may help guide therapy if performed in a timely manner.
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the mycotic ulcer treatment trial a randomized trial comparing Natamycin vs voriconazole
JAMA Ophthalmology, 2013Co-Authors: Venkatesh N Prajna, Muthiah Srinivasan, Tiruvengada Krishnan, Jeena Mascarenhas, Revathi Rajaraman, Lalitha Prajna, Anita Raghavan, Catherine E Oldenburg, Kathryn J Ray, Michael E ZegansAbstract:Objective To compare topical Natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or Natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient = −0.18 logMAR; 95% CI, −0.30 to −0.05; P = .006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio = 0.42; 95% CI, 0.22 to 0.80; P = .009). Fusarium cases fared better with Natamycin than with voriconazole (regression coefficient = −0.41 logMAR; 95% CI, −0.61 to −0.20; P Conclusions Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration clinicaltrials.gov Identifier: NCT00996736
Namperumalsamy Venkatesh Prajna - One of the best experts on this subject based on the ideXlab platform.
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cross linking assisted infection reduction clair a randomized clinical trial evaluating the effect of adjuvant cross linking on microbiological and clinical outcomes in fungal keratitis
Ophthalmology, 2019Co-Authors: Namperumalsamy Venkatesh Prajna, Prajna Lalitha, Thomas M Lietman, Naveen Radhakrishnan, Ariana Austin, Jeremy D Keenan, Travis C Porco, Jennifer RosenussbaumerAbstract:Abstract Objective To determine if there is a benefit to adjuvant corneal crosslinking (CXL) and to compare Natamycin versus amphotericin B for filamentous fungal keratitis. Design Outcome-masked, 2 x 2 factorial design, randomized controlled clinical trial ; Study Participants Consecutive patients presenting with moderate vision loss from a smear-positive fungal ulcer at Aravind Eye Hospital, Madurai, India. Intervention Study eyes were randomized to one of four treatment combinations using an adaptive randomization protocol. The treatment arms included: 1. Topical Natamycin 5% alone, 2. Topical Natamycin 5% plus CXL, 3. Topical amphotericin B 0.15% alone, and 4. Topical amphotericin 0.15% plus CXL. Main Outcome Measures The primary outcome of the trial was microbiological cure at 24 hours on repeat culture. Secondary outcomes included best spectacle corrected visual acuity (BSCVA) at 3 weeks and 3 months, % of study participants with epithelial healing at 3 days, 3 weeks and 3 months, infiltrate and/or scar size at 3 weeks and 3 months, 3-day smear and culture, and adverse events. Results Those randomized to CXL regardless of medication (topical Natamycin or amphotericin) had 1.32-fold increased odds of 24-hour culture positivity although this was not statistically significant (95% CI 0.57 to 3.06; P=0.51). We were also unable to find a difference in 24-hour culture positivity between those randomized to amphotericin compared with Natamycin when evaluating as a group regardless of whether or not they received CXL (coef 1.10, 95% CI 0.47 to 2.54; P=0.84). BSCVA was approximately 0.22 logMAR (2.2 Snellen lines) worse on average at 3 weeks among those receiving CXL regardless of medication (95% CI -0.04 to 0.40, P=0.04) and 0.32-logMAR (3.2 Snellen lines) worse visual acuity at 3 months after controlling for baseline visual acuity (95% CI 0.03 to 0.54; P=0.02). There was no difference in infiltrate and/or scar size, % epithelialized or adverse events when comparing CXL versus no CXL or the two topical medications. Conclusions There appears to be no benefit of adjuvant CXL in the primary treatment of moderate filamentous fungal ulcers and it may result in decreased visual acuity.
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comparison of Natamycin and voriconazole for the treatment of fungal keratitis
Archives of Ophthalmology, 2010Co-Authors: Namperumalsamy Venkatesh Prajna, Muthiah Srinivasan, Tiruvengada Krishnan, Stephen D Mcleod, Jeena Mascarenhas, Lalitha Prajna, Ravindranath P Reddy, C M Vaitilingam, Kevin C Hong, Michael E ZegansAbstract:Objective To conduct a therapeutic exploratory clinical trial comparing clinical outcomes of treatment with topical Natamycin vs topical voriconazole for fungal keratitis. Methods The multicenter, double-masked, clinical trial included 120 patients with fungal keratitis at Aravind Eye Hospital in India who were randomized to receive either topical Natamycin or topical voriconazole and either had repeated scraping of the epithelium or not. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months. Other outcomes included scar size, perforations, and a subanalysis of BSCVA at 3 months in patients with an enrollment visual acuity of 20/40 to 20/400. Results Compared with those who received Natamycin, voriconazole-treated patients had an approximately 1-line improvement in BSCVA at 3 months after adjusting for scraping in a multivariate regression model but the difference was not statistically significant ( P = .29). Scar size at 3 months was slightly greater with voriconazole after adjusting for scraping ( P = .48 ). Corneal perforations in the voriconazole group (10 of 60 patients) were not significantly different than in the Natamycin-treated group (9 of 60 patients) ( P >.99). Scraping was associated with worse BSCVA at 3 months after adjusting for drug ( P = .06). Patients with baseline BSCVA of 20/40 to 20/400 showed a trend toward a 2-line improvement in visual acuity with voriconazole ( P = .07). Conclusions Overall, there were no significant differences in visual acuity, scar size, and perforations between voriconazole- and Natamycin-treated patients. There was a trend toward scraping being associated with worse outcomes. Application to Clinical Practice The benefit seen with voriconazole in the subgroup of patients with baseline visual acuity of 20/40 to 20/400 needs to be validated in a confirmatory clinical trial. Trial Registration clinicaltrials.gov Identifier:NCT00557362
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in vitro Natamycin susceptibility of ocular isolates of fusarium and aspergillus species comparison of commercially formulated Natamycin eye drops to pharmaceutical grade powder
Journal of Clinical Microbiology, 2008Co-Authors: Prajna Lalitha, R Vijaykumar, Namperumalsamy Venkatesh Prajna, Annette W FothergillAbstract:The Clinical and Laboratory Standards Institute susceptibility method prohibits the use of pharmacy preparations, but obtaining pure powders is difficult. The activity of Natamycin against isolates of Aspergillus and Fusarium species isolated from keratitis was assessed by using both powder and pharmacy eye drop preparations. Eye drop preparations may be a viable option for testing Natamycin activity.
