Pub Date : 2024-11-13eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S485199
Jennifer L Patnaik, Amy Dye-Robinson, Katherine A James, Malik Y Kahook
Background: The World Health Organization has declared climate change to be "the single biggest health threat facing humanity", yet there are limited studies on the impact of climate change-related air pollution on ocular health.
Objective: To explore associations between ocular surface irritation and allergy-related daily outpatient office visits with daily ambient particulate matter (PM) levels in the Denver Metropolitan Area.
Methods: Daily visit counts of ophthalmology outpatient offices were obtained from an academic health center (October 1st, 2015 to January 27th, 2023). Daily ambient average concentrations of PM ≤ 10 µm in diameter (PM10) and 2.5 micrometers or less in diameter (PM2.5) were obtained. Data were analyzed using distributed lag nonlinear models while accounting for the cumulative lagged effects of PM10 and PM2.5 for visits. Modifications due to temperature were assessed using stratified models.
Results: There were 144,313 ocular surface irritation and allergy visits to ophthalmic clinics during the study period. Daily visit counts increased with increasing daily ambient PM10 and PM2.5 concentrations. Five-day cumulative ambient PM10 concentrations at 80, 90, 100, and 110 µg/m3 showed higher rate ratios at each level from 1.77 (95% CI: 1.71, 1.84) at concentration of 80 to 2.20 (95% CI: 2.09, 2.30) for concentration of 110 µg/m3. Similarly, the visit rate ratios increased as the daily PM2.5 concentration increased, but this gradient effect was not significantly higher as the concentration increased. The effect of PM10 was higher on days when the temperature was below the average. Temperature did not affect the association between daily visit counts and PM2.5.
Conclusion: This study found that ambient PM increased the rate of ophthalmology visits due to ocular surface irritation and allergies. Most importantly, this association increased in magnitude with higher ambient PM concentrations. Additional studies are required to fully understand the effects of climate change-related stressors on ocular health.
{"title":"Association Between Particulate Matter Pollutants and Ophthalmology Visits for Ocular Surface Irritation and Allergy.","authors":"Jennifer L Patnaik, Amy Dye-Robinson, Katherine A James, Malik Y Kahook","doi":"10.2147/OPTH.S485199","DOIUrl":"https://doi.org/10.2147/OPTH.S485199","url":null,"abstract":"<p><strong>Background: </strong>The World Health Organization has declared climate change to be \"the single biggest health threat facing humanity\", yet there are limited studies on the impact of climate change-related air pollution on ocular health.</p><p><strong>Objective: </strong>To explore associations between ocular surface irritation and allergy-related daily outpatient office visits with daily ambient particulate matter (PM) levels in the Denver Metropolitan Area.</p><p><strong>Methods: </strong>Daily visit counts of ophthalmology outpatient offices were obtained from an academic health center (October 1<sup>st</sup>, 2015 to January 27<sup>th</sup>, 2023). Daily ambient average concentrations of PM ≤ 10 µm in diameter (PM<sub>10</sub>) and 2.5 micrometers or less in diameter (PM<sub>2.5</sub>) were obtained. Data were analyzed using distributed lag nonlinear models while accounting for the cumulative lagged effects of PM<sub>10</sub> and PM<sub>2.5</sub> for visits. Modifications due to temperature were assessed using stratified models.</p><p><strong>Results: </strong>There were 144,313 ocular surface irritation and allergy visits to ophthalmic clinics during the study period. Daily visit counts increased with increasing daily ambient PM<sub>10</sub> and PM<sub>2.5</sub> concentrations. Five-day cumulative ambient PM<sub>10</sub> concentrations at 80, 90, 100, and 110 µg/m<sup>3</sup> showed higher rate ratios at each level from 1.77 (95% CI: 1.71, 1.84) at concentration of 80 to 2.20 (95% CI: 2.09, 2.30) for concentration of 110 µg/m<sup>3</sup>. Similarly, the visit rate ratios increased as the daily PM<sub>2.5</sub> concentration increased, but this gradient effect was not significantly higher as the concentration increased. The effect of PM<sub>10</sub> was higher on days when the temperature was below the average. Temperature did not affect the association between daily visit counts and PM<sub>2.5</sub>.</p><p><strong>Conclusion: </strong>This study found that ambient PM increased the rate of ophthalmology visits due to ocular surface irritation and allergies. Most importantly, this association increased in magnitude with higher ambient PM concentrations. Additional studies are required to fully understand the effects of climate change-related stressors on ocular health.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11569711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-13eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S488581
Justin Spaulding, Brad Hall
Purpose: To evaluate the efficiency of a hybrid tip in removing cataract grade 3 and 4 in high and low intraocular pressure (IOP) settings.
Methods: This was a randomized, prospective, double-arm contralateral eye study. One randomized eye of each subject had phacoemulsification with high IOP settings (50 mmHg) while the other eye had phacoemulsification with low IOP settings (20 mmHg). Operative endpoints included phaco time, aspiration time, fluid use, cumulative dissipated energy (CDE), total case time, total torsional time, and total longitudinal time. Postoperative endpoints included central corneal thickness (CCT), and IOP.
Results: A total of 102 eyes (51 patients) completed the study. Phaco time in grade 3 and grade 4 cataracts were 38.4 ± 9.6 s and 44.1 ± 9.9 s in the high group, respectively, and 38.9 ± 8.6 s and 46.3 ± 11.0 s in the low group, respectively. Aspiration time in grade 3 and grade 4 cataracts were 95.3 ± 21.2 s and 111.8 ± 32.8 s in the high group, respectively, and 105.4 ± 27.0 s and 108.6 ± 23.1 s in the low group, respectively. Fluid volume used in grade 3 and grade 4 cataracts were 39.2 ± 6.8 mL and 45.2 ± 10.8 mL in the high group, respectively, and 38.3 ± 7.3 mL and 43.2 ± 8.0 mL in the low group, respectively. The CDE in grade 3 and grade 4 cataracts were 7.8 ± 2.6 and 10.2 ± 3.2 in the high group, respectively, and 7.7 ± 2.2 and 9.9 ± 4.5 in the low group, respectively.
Conclusion: Results suggest that a hybrid phacoemulsification tip was efficient in removing cataracts of grade 3 and grade 4 with high and low IOP settings.
{"title":"The Cutting Efficiency of a Hybrid Phacoemulsification Tip Using High and Low Intraocular Pressure Settings in Different Grades of Cataract.","authors":"Justin Spaulding, Brad Hall","doi":"10.2147/OPTH.S488581","DOIUrl":"https://doi.org/10.2147/OPTH.S488581","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the efficiency of a hybrid tip in removing cataract grade 3 and 4 in high and low intraocular pressure (IOP) settings.</p><p><strong>Methods: </strong>This was a randomized, prospective, double-arm contralateral eye study. One randomized eye of each subject had phacoemulsification with high IOP settings (50 mmHg) while the other eye had phacoemulsification with low IOP settings (20 mmHg). Operative endpoints included phaco time, aspiration time, fluid use, cumulative dissipated energy (CDE), total case time, total torsional time, and total longitudinal time. Postoperative endpoints included central corneal thickness (CCT), and IOP.</p><p><strong>Results: </strong>A total of 102 eyes (51 patients) completed the study. Phaco time in grade 3 and grade 4 cataracts were 38.4 ± 9.6 s and 44.1 ± 9.9 s in the high group, respectively, and 38.9 ± 8.6 s and 46.3 ± 11.0 s in the low group, respectively. Aspiration time in grade 3 and grade 4 cataracts were 95.3 ± 21.2 s and 111.8 ± 32.8 s in the high group, respectively, and 105.4 ± 27.0 s and 108.6 ± 23.1 s in the low group, respectively. Fluid volume used in grade 3 and grade 4 cataracts were 39.2 ± 6.8 mL and 45.2 ± 10.8 mL in the high group, respectively, and 38.3 ± 7.3 mL and 43.2 ± 8.0 mL in the low group, respectively. The CDE in grade 3 and grade 4 cataracts were 7.8 ± 2.6 and 10.2 ± 3.2 in the high group, respectively, and 7.7 ± 2.2 and 9.9 ± 4.5 in the low group, respectively.</p><p><strong>Conclusion: </strong>Results suggest that a hybrid phacoemulsification tip was efficient in removing cataracts of grade 3 and grade 4 with high and low IOP settings.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11569703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-12eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S503948
Jessica Galvan, Leissa Iorranne Costa Gil de Sousa, Ricardo Luz Leitão Guerra
{"title":"Enhancing OCT Reliability: The Role of Eye-Tracking in Achieving Consistent Retinal Measurements [Letter].","authors":"Jessica Galvan, Leissa Iorranne Costa Gil de Sousa, Ricardo Luz Leitão Guerra","doi":"10.2147/OPTH.S503948","DOIUrl":"https://doi.org/10.2147/OPTH.S503948","url":null,"abstract":"","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-12eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S488232
Sujeeth Krishna Shanmugam, David J Browning
Purpose: Compare large language models (LLMs) in analyzing and responding to a difficult series of ophthalmic cases.
Design: A comparative case series involving LLMs that met inclusion criteria tested on twenty difficult case studies posed in open-text format.
Methods: Fifteen LLMs accessible to ophthalmologists were tested against twenty case studies published in JAMA Ophthalmology. Each case was presented in identical, open-ended text fashion to each LLM and open-ended responses regarding differential diagnosis, next diagnostic tests and recommended treatments were requested. Responses were recorded and assessed for accuracy against published correct answers. The main outcome was accuracy of LLMs against the correct answers. Secondary outcomes included comparative performance on the differential diagnosis, ancillary testing, and treatment subtests; and readability of responses.
Results: Scores were normally distributed and ranged from 0-35 (with a maximum score of 60) with a mean ± standard deviation of 19 ± 9. Scores for three of the LLMs (ChatGPT 3.5, Claude Pro, and Copilot Pro) were statistically significantly higher than the mean. Two of the high-performing LLMs were paid subscription (Claude Pro and Copilot Pro) and one was free (ChatGPT 3.5). While there were no clinical or statistical differences between ChatGPT 3.5 and Claude Pro, a separation of +5 points, or 0.56 standard deviations, between Copilot Pro and the other highly ranked LLMs was present. Readability of all tested programs were above the AMA (American Medical Association) reading level recommendations to public consumers of eight grade.
Conclusion: Subscription LLMs were more prevalent among highly ranked LLMs suggesting that these perform better as ophthalmic assistants. While readability was poor for the average person, the content was understood by a board-certified ophthalmologist. The accuracy of LLMs is not high enough to recommend patient care in standalone mode, but aiding clinicians in patient care and prevent oversights is promising.
{"title":"Comparison of Large Language Models in Diagnosis and Management of Challenging Clinical Cases.","authors":"Sujeeth Krishna Shanmugam, David J Browning","doi":"10.2147/OPTH.S488232","DOIUrl":"https://doi.org/10.2147/OPTH.S488232","url":null,"abstract":"<p><strong>Purpose: </strong>Compare large language models (LLMs) in analyzing and responding to a difficult series of ophthalmic cases.</p><p><strong>Design: </strong>A comparative case series involving LLMs that met inclusion criteria tested on twenty difficult case studies posed in open-text format.</p><p><strong>Methods: </strong>Fifteen LLMs accessible to ophthalmologists were tested against twenty case studies published in JAMA Ophthalmology. Each case was presented in identical, open-ended text fashion to each LLM and open-ended responses regarding differential diagnosis, next diagnostic tests and recommended treatments were requested. Responses were recorded and assessed for accuracy against published correct answers. The main outcome was accuracy of LLMs against the correct answers. Secondary outcomes included comparative performance on the differential diagnosis, ancillary testing, and treatment subtests; and readability of responses.</p><p><strong>Results: </strong>Scores were normally distributed and ranged from 0-35 (with a maximum score of 60) with a mean ± standard deviation of 19 ± 9. Scores for three of the LLMs (ChatGPT 3.5, Claude Pro, and Copilot Pro) were statistically significantly higher than the mean. Two of the high-performing LLMs were paid subscription (Claude Pro and Copilot Pro) and one was free (ChatGPT 3.5). While there were no clinical or statistical differences between ChatGPT 3.5 and Claude Pro, a separation of +5 points, or 0.56 standard deviations, between Copilot Pro and the other highly ranked LLMs was present. Readability of all tested programs were above the AMA (American Medical Association) reading level recommendations to public consumers of eight grade.</p><p><strong>Conclusion: </strong>Subscription LLMs were more prevalent among highly ranked LLMs suggesting that these perform better as ophthalmic assistants. While readability was poor for the average person, the content was understood by a board-certified ophthalmologist. The accuracy of LLMs is not high enough to recommend patient care in standalone mode, but aiding clinicians in patient care and prevent oversights is promising.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-11eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S465694
Jay Mashouf, Keith Wan, Brad Hall
Purpose: To evaluate the subjective wearing experience of lehfilcon A toric lenses among subjects who were already satisfied with their comfilcon A toric lenses.
Methods: This was an open-label, single arm study of currently satisfied comfilcon A soft toric contact lens (Biofinity Toric, CooperVision, Pleasanton, CA) wearers that were refit with lehfilcon A soft toric lenses (Total30® for Astigmatism; Alcon Vision LLC, Fort Worth, TX). Subjects were administered a questionnaire about satisfaction with comfort, visual performance, end of day comfort, and ease of handling with lehfilcon A toric lenses.
Results: A total of 40 subjects completed the study. After one month of wear the median and interquartile range (IQR) was 8 (2) for overall satisfaction with lehfilcon A comfort, 8 (1.25) for visual performance, 7 (3.25) for end of day comfort, 9 (2) for ease of handling, and finally 8 (2) for overall satisfaction.
Conclusion: A high proportion of subjects were satisfied with the subjective wearing experience with lehfilcon A toric lenses, including satisfaction with comfort, visual performance, end of day comfort, and ease of handling.
{"title":"Subjective Wearing Experience of Lehfilcon A Among Satisfied Comfilcon A Toric Lens Wearers.","authors":"Jay Mashouf, Keith Wan, Brad Hall","doi":"10.2147/OPTH.S465694","DOIUrl":"https://doi.org/10.2147/OPTH.S465694","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the subjective wearing experience of lehfilcon A toric lenses among subjects who were already satisfied with their comfilcon A toric lenses.</p><p><strong>Methods: </strong>This was an open-label, single arm study of currently satisfied comfilcon A soft toric contact lens (Biofinity Toric, CooperVision, Pleasanton, CA) wearers that were refit with lehfilcon A soft toric lenses (Total30<sup>®</sup> for Astigmatism; Alcon Vision LLC, Fort Worth, TX). Subjects were administered a questionnaire about satisfaction with comfort, visual performance, end of day comfort, and ease of handling with lehfilcon A toric lenses.</p><p><strong>Results: </strong>A total of 40 subjects completed the study. After one month of wear the median and interquartile range (IQR) was 8 (2) for overall satisfaction with lehfilcon A comfort, 8 (1.25) for visual performance, 7 (3.25) for end of day comfort, 9 (2) for ease of handling, and finally 8 (2) for overall satisfaction.</p><p><strong>Conclusion: </strong>A high proportion of subjects were satisfied with the subjective wearing experience with lehfilcon A toric lenses, including satisfaction with comfort, visual performance, end of day comfort, and ease of handling.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568563/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-11eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S483004
Pamela L Nguyen, Jose Amezcua Moreno, Diep Tran, Kathleen McHugh, Fasika A Woreta, Megan E Collins, Cindy X Cai
Purpose: To characterize the baseline characteristics and clinical outcomes of patients seen through the Free Diabetic Screening (FDS) program, a free diabetic retinopathy screening program for uninsured patients, in the ophthalmology resident clinic at the Wilmer Eye Institute.
Patients and methods: This retrospective longitudinal cohort study included uninsured patients ≥18 years with diabetes mellitus seen through the FDS clinic from 2013 to 2023. Data extraction was performed using manual chart review of the first FDS visit, and automated extraction of the data warehouse related to all other office visits. Patient demographic and clinical characteristics at presentation, treatments, and follow-ups were collected.
Results: A total of 422 patients were included in this study (mean age 52 years; 59% female; 47% Hispanic; 49% Spanish as primary language). One-third of patients had some form of diabetic retinopathy or diabetic macular edema, and 12% had vision-threatening diabetic retinopathy at presentation. In all, nearly 10% of patients were referred for further specialty care, and 71% of these patients completed at least one follow-up visit. The majority of patients (55%) returned for care as recommended and were followed for a mean length of 200 weeks and 10 office visits.
Conclusion: The FDS clinic provided much needed diabetic retinopathy screening and treatment for uninsured patients in Baltimore City and surrounding areas. This study highlights the need for strong integration between initial screening and downstream services, as nearly 10% of patients require further sub-specialty intervention or care.
{"title":"Baseline Characteristics and Clinical Outcomes of Patients Seen Through the Free Diabetes Screening (FDS) Program.","authors":"Pamela L Nguyen, Jose Amezcua Moreno, Diep Tran, Kathleen McHugh, Fasika A Woreta, Megan E Collins, Cindy X Cai","doi":"10.2147/OPTH.S483004","DOIUrl":"https://doi.org/10.2147/OPTH.S483004","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize the baseline characteristics and clinical outcomes of patients seen through the Free Diabetic Screening (FDS) program, a free diabetic retinopathy screening program for uninsured patients, in the ophthalmology resident clinic at the Wilmer Eye Institute.</p><p><strong>Patients and methods: </strong>This retrospective longitudinal cohort study included uninsured patients ≥18 years with diabetes mellitus seen through the FDS clinic from 2013 to 2023. Data extraction was performed using manual chart review of the first FDS visit, and automated extraction of the data warehouse related to all other office visits. Patient demographic and clinical characteristics at presentation, treatments, and follow-ups were collected.</p><p><strong>Results: </strong>A total of 422 patients were included in this study (mean age 52 years; 59% female; 47% Hispanic; 49% Spanish as primary language). One-third of patients had some form of diabetic retinopathy or diabetic macular edema, and 12% had vision-threatening diabetic retinopathy at presentation. In all, nearly 10% of patients were referred for further specialty care, and 71% of these patients completed at least one follow-up visit. The majority of patients (55%) returned for care as recommended and were followed for a mean length of 200 weeks and 10 office visits.</p><p><strong>Conclusion: </strong>The FDS clinic provided much needed diabetic retinopathy screening and treatment for uninsured patients in Baltimore City and surrounding areas. This study highlights the need for strong integration between initial screening and downstream services, as nearly 10% of patients require further sub-specialty intervention or care.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142650002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Purpose: To evaluate the tolerability of utilizing Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) as a drug delivery device for preservative-free cyclosporine 0.05% for the treatment of dry eye disease.
Patients and methods: Fourteen current daily PROSE wearers were enrolled, with four screen failures and one subject that did not complete the study protocol due to burning and stinging. Nine subjects, 18 eyes completed the study protocol. All participants were instructed to instill one drop of preservative-free cyclosporine 0.05% in the PROSE reservoir and then fill the rest of the reservoir with preservative-free normal saline. After applying the PROSE and wearing for 6 hours, the PROSE was removed, and the protocol was repeated for at least another 4 additional hours of wear. Baseline, 1 week and 1 month symptom and sign data were collected.
Results: At one month, OSDI improved by an average of 3.83 ± 6.87 from baseline (p = 0.07) and there was no statistically significant change in best corrected visual acuity. Without comparing with placebo, there was statistically significant (p < 0.05) improvement in mean per subject and mean per eye corneal fluorescein staining, conjunctival lissamine staining, and conjunctival hyperemia by slit lamp examination at one-month follow-up.
Conclusion: Utilizing PROSE as a drug delivery system for non-preserved cyclosporine 0.05% was well tolerated in regard to both ocular symptoms and ocular surface signs. Results from this pilot study are suggestive of efficacy. The results of this study support progressing this protocol to a larger scale randomized controlled double blinded prospective clinical trial.
{"title":"Utilizing PROSE as a Drug Delivery Device for Preservative-Free Cyclosporine 0.05% for the Treatment of Dry Eye Disease: A Pilot Study.","authors":"Monica Nabil Nakhla, Ria Patel, Estelle Crowley, Yichen Li, Thelge Buddika Peiris, Daniel Brocks","doi":"10.2147/OPTH.S487369","DOIUrl":"10.2147/OPTH.S487369","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the tolerability of utilizing Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) as a drug delivery device for preservative-free cyclosporine 0.05% for the treatment of dry eye disease.</p><p><strong>Patients and methods: </strong>Fourteen current daily PROSE wearers were enrolled, with four screen failures and one subject that did not complete the study protocol due to burning and stinging. Nine subjects, 18 eyes completed the study protocol. All participants were instructed to instill one drop of preservative-free cyclosporine 0.05% in the PROSE reservoir and then fill the rest of the reservoir with preservative-free normal saline. After applying the PROSE and wearing for 6 hours, the PROSE was removed, and the protocol was repeated for at least another 4 additional hours of wear. Baseline, 1 week and 1 month symptom and sign data were collected.</p><p><strong>Results: </strong>At one month, OSDI improved by an average of 3.83 ± 6.87 from baseline (p = 0.07) and there was no statistically significant change in best corrected visual acuity. Without comparing with placebo, there was statistically significant (p < 0.05) improvement in mean per subject and mean per eye corneal fluorescein staining, conjunctival lissamine staining, and conjunctival hyperemia by slit lamp examination at one-month follow-up.</p><p><strong>Conclusion: </strong>Utilizing PROSE as a drug delivery system for non-preserved cyclosporine 0.05% was well tolerated in regard to both ocular symptoms and ocular surface signs. Results from this pilot study are suggestive of efficacy. The results of this study support progressing this protocol to a larger scale randomized controlled double blinded prospective clinical trial.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559178/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-09eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S475331
Sujata P Sarda, Guillaume Germain, Malena Mahendran, Jacob Klimek, Wendy Y Cheng, Roger Luo, Mei Sheng Duh
Purpose: This study assessed the clinical and economic burden of geographic atrophy (GA) using real-world data from elderly patients with Medicare Advantage plans in the United States.
Patients and methods: A retrospective cohort design of patients with GA only, GA + visual impairment (GA + VI), GA + blindness (GA + B), and patients without GA were identified using administrative healthcare claims data from Optum Clinformatics Data Mart. Inverse probability of treatment weighting controlled for confounding when comparing patients with GA only vs without GA, GA + VI vs GA only, and GA + B vs GA only. Endpoints included all-cause and ophthalmic condition-related healthcare resource utilization (HRU), injurious falls, and healthcare costs. HRU and injurious falls were assessed per-person-per-year and per 100 person-years, respectively. Cohorts were compared using rate ratios, 95% confidence intervals (CIs), and p-values from weighted Poisson regression models. Healthcare costs were evaluated per-person-per-year using mean cost differences, 95% CIs, and p-values from weighted linear regression.
Results: The study included 18,119 patients with GA only, 2,285 with GA + VI, 1,716 with GA + B, and 72,476 patients without GA. Higher rates of all-cause hospitalizations (RR [95% CI]: 1.08 [1.03, 1.12]), outpatient visits (1.08 [1.05, 1.10]), other visits (1.14 [1.08, 1.21]), and falls with head injuries (1.24 [1.05, 1.45]) were observed in patients with GA vs without GA (P<0.05). GA was associated with higher annual all-cause total healthcare costs, spending an average of $1,171 more after adjustment (P<0.05). Progression to GA + VI and GA + B was associated with a more pronounced burden.
Conclusion: The clinical and economic burden of GA is substantial and escalates as the disease advances. These findings suggest early intervention aimed at slowing GA progression may help to mitigate the healthcare burden associated with advancement of GA to visual impairment and blindness.
目的:本研究利用美国医疗保险优势计划(Medicare Advantage Plan)老年患者的真实数据,评估了地理萎缩(GA)的临床和经济负担:利用 Optum Clinformatics Data Mart 中的行政医疗索赔数据,对仅患有地心性萎缩的患者、患有地心性萎缩+视力障碍(GA + VI)的患者、患有地心性萎缩+失明(GA + B)的患者以及不患有地心性萎缩的患者进行了回顾性队列设计。在比较仅有 GA 与没有 GA、GA + VI 与仅有 GA 和 GA + B 与仅有 GA 的患者时,治疗的逆概率加权控制了混杂因素。终点包括全因和眼科疾病相关的医疗资源利用率(HRU)、伤害性跌倒和医疗成本。HRU和伤害性跌倒分别按每人每年和每100人每年进行评估。使用加权泊松回归模型中的比率比、95% 置信区间(CI)和 p 值对各组进行比较。使用加权线性回归的平均成本差异、95% 置信区间和 p 值对每人每年的医疗成本进行评估:研究包括 18119 名仅患有 GA 的患者、2285 名患有 GA + VI 的患者、1716 名患有 GA + B 的患者以及 72476 名未患有 GA 的患者。观察发现,GA 患者与非 GA 患者的全因住院率(RR [95% CI]:1.08 [1.03, 1.12])、门诊就诊率(1.08 [1.05, 1.10])、其他就诊率(1.14 [1.08, 1.21])和头部受伤跌倒率(1.24 [1.05, 1.45])均较高:GA造成的临床和经济负担巨大,并随着病情的发展而不断加重。这些研究结果表明,旨在减缓GA进展的早期干预措施可能有助于减轻因GA发展为视力损伤和失明而带来的医疗负担。
{"title":"Real-World Healthcare Resource Utilization, Healthcare Costs, and Injurious Falls Among Elderly Patients with Geographic Atrophy.","authors":"Sujata P Sarda, Guillaume Germain, Malena Mahendran, Jacob Klimek, Wendy Y Cheng, Roger Luo, Mei Sheng Duh","doi":"10.2147/OPTH.S475331","DOIUrl":"10.2147/OPTH.S475331","url":null,"abstract":"<p><strong>Purpose: </strong>This study assessed the clinical and economic burden of geographic atrophy (GA) using real-world data from elderly patients with Medicare Advantage plans in the United States.</p><p><strong>Patients and methods: </strong>A retrospective cohort design of patients with GA only, GA + visual impairment (GA + VI), GA + blindness (GA + B), and patients without GA were identified using administrative healthcare claims data from Optum Clinformatics Data Mart. Inverse probability of treatment weighting controlled for confounding when comparing patients with GA only vs without GA, GA + VI vs GA only, and GA + B vs GA only. Endpoints included all-cause and ophthalmic condition-related healthcare resource utilization (HRU), injurious falls, and healthcare costs. HRU and injurious falls were assessed per-person-per-year and per 100 person-years, respectively. Cohorts were compared using rate ratios, 95% confidence intervals (CIs), and p-values from weighted Poisson regression models. Healthcare costs were evaluated per-person-per-year using mean cost differences, 95% CIs, and p-values from weighted linear regression.</p><p><strong>Results: </strong>The study included 18,119 patients with GA only, 2,285 with GA + VI, 1,716 with GA + B, and 72,476 patients without GA. Higher rates of all-cause hospitalizations (RR [95% CI]: 1.08 [1.03, 1.12]), outpatient visits (1.08 [1.05, 1.10]), other visits (1.14 [1.08, 1.21]), and falls with head injuries (1.24 [1.05, 1.45]) were observed in patients with GA vs without GA (P<0.05). GA was associated with higher annual all-cause total healthcare costs, spending an average of $1,171 more after adjustment (P<0.05). Progression to GA + VI and GA + B was associated with a more pronounced burden.</p><p><strong>Conclusion: </strong>The clinical and economic burden of GA is substantial and escalates as the disease advances. These findings suggest early intervention aimed at slowing GA progression may help to mitigate the healthcare burden associated with advancement of GA to visual impairment and blindness.</p>","PeriodicalId":93945,"journal":{"name":"Clinical ophthalmology (Auckland, N.Z.)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142634611","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-08eCollection Date: 2024-01-01DOI: 10.2147/OPTH.S479852
Gábor Hollo
The preservative-free fixed-dose combination formulation of 0.0015% tafluprost and 0.5% timolol (PF tafluprost/timolol FC) is among the topical intraocular pressure (IOP)-lowering therapies commonly used second-line for the management of ocular hypertension (OHT) and open-angle glaucoma (OAG), according to recommended treatment pathways. A growing body of evidence has developed in recent years regarding efficacy, safety and tolerability outcomes with PF tafluprost/timolol FC in both randomized controlled trials (RCTs) and real-life studies. This review aims to summarize key evidence from published Phase IV trials and real-life studies to highlight those data that complement RCT findings and support implementation of evidence-informed clinical practice. Real-life efficacy and safety outcomes are discussed through the lens of common clinical scenarios that ophthalmologists may encounter in the management of OHT/OAG. Phase IV studies conducted to date have demonstrated that the majority of OHT/OAG patients insufficiently controlled on topical prostaglandin or beta-blocker monotherapy may achieve IOP reductions of ≥20% following a switch to PF tafluprost/timolol FC therapy. Statistically significant IOP reductions were reported from 4 weeks and maintained through 6 months. Real-life studies and case series data also indicated that patients with poor IOP control on maximal/complex topical regimens benefited from a step down to PF tafluprost/timolol FC therapy, achieving significant and sustained IOP reductions. A number of studies have shown improvements in tolerability and the signs and symptoms of ocular health with PF tafluprost/timolol FC therapy, both in patients stepping up from monotherapy and in those simplifying their topical regimen. Clinicians reported better treatment adherence with PF tafluprost/timolol FC compared with prior treatments, which may have been associated with enhanced patient experience regarding treatment tolerability and is likely to have contributed to the long-term IOP-lowering efficacy outcomes observed. Real-life safety data for PF tafluprost/timolol FC reflect outcomes reported in published RCTs.
根据推荐的治疗路径,0.0015%他氟前列素和0.5%噻吗洛尔的无防腐剂固定剂量联合制剂(PF他氟前列素/噻吗洛尔FC)是眼压(IOP)降低的局部疗法之一,常用于眼压过高(OHT)和开角型青光眼(OAG)的二线治疗。近年来,在随机对照试验(RCT)和实际生活研究中,有关PF他氟前列素/噻吗洛尔FC的疗效、安全性和耐受性的证据越来越多。本综述旨在总结已发表的第 IV 期试验和实际生活研究中的关键证据,以突出那些能补充随机对照试验结果并支持实施循证临床实践的数据。本综述从眼科医生在治疗 OHT/OAG 时可能遇到的常见临床情况出发,讨论了现实生活中的疗效和安全性结果。迄今为止进行的 IV 期研究表明,大多数接受局部前列腺素或β-受体阻滞剂单药治疗但眼压控制不佳的 OHT/OAG 患者在改用 PF 他氟前列素/噻吗洛尔 FC 治疗后,眼压可降低≥20%。据报道,从 4 周开始,眼压就会出现统计学意义上的明显下降,并可维持 6 个月。现实生活中的研究和病例系列数据也表明,使用最大/复合局部治疗方案时眼压控制不佳的患者,在降为 PF 他氟前列素/噻吗洛尔 FC 治疗后也能获益,实现显著且持续的眼压降低。许多研究表明,无论是从单一疗法中逐步过渡到帕夫前列素/噻吗洛尔FC疗法的患者,还是简化局部疗法的患者,其耐受性以及眼部健康的症状和体征都有所改善。据临床医生报告,与之前的治疗方法相比,PF 他氟前列素/噻吗洛尔 FC 的治疗依从性更好,这可能与患者对治疗耐受性的体验增强有关,也可能有助于观察到的长期降低眼压疗效。帕夫前列素/噻吗洛尔FC的实际安全性数据反映了已发表的RCT报告的结果。
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Purpose: While the safety and efficacy of PFHO has been demonstrated in non-contact lens wearers, its safety and potential benefits in habitual contact lens wearers have not been explored. This report presents the results of a trial designed to evaluate the safety of PFHO and its effect on contact lens comfort, specifically in established contact lens wearers.
Patients and methods: The study included 47 patients who were adjusted contact lens wearers with a best corrected visual acuity of 20/25 or better at distance. All the patients were healthy contact lens wearers with no dry eye symptoms.
Results: A significant improvement in comfort scoring was observed without any significant changes in osmolarity, meibography scores, and total fluorescein staining.
Conclusion: These findings suggest that PCHO is safe for contact lens wearers to use and shows promise to reduce contact lens dropout.