BMJ Open Ophthalmology最新文献

{"title":"Effects of myopia on health-related quality of life in adolescents: a population-based cross-sectional causal empirical survey.","authors":"Liyong Lu, Yu Zheng, Yanjiao Xu, Junchao Feng, Shunping Li","doi":"10.1136/bmjophth-2024-001730","DOIUrl":"https://doi.org/10.1136/bmjophth-2024-001730","url":null,"abstract":"<p><strong>Objective: </strong>Myopia is a prevalent disease affecting adolescent vision and harms various health outcomes. However, the evidence about the effects of myopia on adolescents' overall health status is limited. Using health-related quality of life (HRQoL), a comprehensive health measurement indicator, this study aims to evaluate the effects of myopia on adolescents' HRQoL.</p><p><strong>Methods and analysis: </strong>Adolescents' HRQoL was measured by the Child Health Utility 9D instrument. Data were collected from a population-based cross-sectional survey conducted in Shandong province of China. To mitigate the potential endogeneity bias, parents' myopia degree was used as the instrumental variable for adolescents' myopia status. The causal model was built to explore the effects and potential mediators of myopia on the HRQoL of adolescents. Heterogeneity analysis was used to identify susceptible groups.</p><p><strong>Results: </strong>108 657 adolescents with an average age of 12 were included in the analysis. Compared with adolescents without myopia, the health utility value of individuals with low, moderate and high decreases by 0.5%, 1.1% and 2.2%, respectively. The reduction of outdoor activity time and increase in electronic device usage time play the mediator role. Myopia leads to a greater decrease in the health utility value of adolescents in higher grades, boarding schools and low-income households compared with their counterparts.</p><p><strong>Conclusion: </strong>Myopia impairs adolescents' HRQoL and damages the overall health level of adolescents. The frequency of outdoor activity and electronic device usage could be the potential mediators. The susceptibility of adolescents in higher grades, boarding schools and low-income households would be exacerbated.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial intelligence chatbots as sources of patient education material for cataract surgery: ChatGPT-4 versus Google Bard.","authors":"Matthew Azzopardi, Benjamin Ng, Abison Logeswaran, Constantinos Loizou, Ryan Chin Taw Cheong, Prasanth Gireesh, Darren Shu Jeng Ting, Yu Jeat Chong","doi":"10.1136/bmjophth-2024-001824","DOIUrl":"https://doi.org/10.1136/bmjophth-2024-001824","url":null,"abstract":"<p><strong>Objective: </strong>To conduct a head-to-head comparative analysis of cataract surgery patient education material generated by Chat Generative Pre-trained Transformer (ChatGPT-4) and Google Bard.</p><p><strong>Methods and analysis: </strong>98 frequently asked questions on cataract surgery in English were taken in November 2023 from 5 trustworthy online patient information resources. 59 of these were curated (20 augmented for clarity and 39 duplicates excluded) and categorised into 3 domains: condition (n=15), preparation for surgery (n=21) and recovery after surgery (n=23). They were formulated into input prompts with 'prompt engineering'. Using the Patient Education Materials Assessment Tool-Printable (PEMAT-P) Auto-Scoring Form, four ophthalmologists independently graded ChatGPT-4 and Google Bard responses. The readability of responses was evaluated using a Flesch-Kincaid calculator. Responses were also subjectively examined for any inaccurate or harmful information.</p><p><strong>Results: </strong>Google Bard had a higher mean overall Flesch-Kincaid Level (8.02) compared with ChatGPT-4 (5.75) (p<0.001), also noted across all three domains. ChatGPT-4 had a higher overall PEMAT-P understandability score (85.8%) in comparison to Google Bard (80.9%) (p<0.001), which was also noted in the 'preparation for cataract surgery' (85.2% vs 75.7%; p<0.001) and 'recovery after cataract surgery' (86.5% vs 82.3%; p=0.004) domains. There was no statistically significant difference in overall (42.5% vs 44.2%; p=0.344) or individual domain actionability scores (p>0.10). None of the generated material contained dangerous information.</p><p><strong>Conclusion: </strong>In comparison to Google Bard, ChatGPT-4 fared better overall, scoring higher on the PEMAT-P understandability scale and exhibiting more faithfulness to the prompt engineering instruction. Since input prompts might vary from real-world patient searches, follow-up studies with patient participation are required.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487885/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458517","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}

{"title":"Putting efficacy into context: do controlled trials on efficacy of myopia control translate to a clinical population?","authors":"Stephanie Kearney, Mhairi Day","doi":"10.1136/bmjophth-2024-001921","DOIUrl":"https://doi.org/10.1136/bmjophth-2024-001921","url":null,"abstract":"","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11487821/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458533","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}

{"title":"Patient preferences for ocular hypertension monitoring: a discrete choice experiment.","authors":"Hangjian Wu, Rodolfo Hernández, David P Crabb, Gus Gazzard, Robert A Harper, Anthony King, James E Morgan, Yemisi Takwoingi, Augusto Azuara-Blanco, Verity Watson","doi":"10.1136/bmjophth-2024-001639","DOIUrl":"10.1136/bmjophth-2024-001639","url":null,"abstract":"<p><strong>Background/aims: </strong>To elicit the preferences and calculate the willingness to pay (WTP) of patients with ocular hypertension (OHT) for eye monitoring services in the UK.</p><p><strong>Methods: </strong>Patients with OHT aged at least 18 years recruited from four NHS ophthalmology departments were included in the study. Patients' preferences and WTP for an OHT monitoring service in the National Health Service were elicited using a discrete choice experiment (DCE) within a postal survey based on six attributes: (1) how OHT monitoring is organised, (2) monitoring frequency, (3) travel time from home, (4) use of a risk calculator for conversion to glaucoma, (5) risk of developing glaucoma in the next 10 years and (6) cost of monitoring. We used a sequential mixed-methods approach to design the survey.</p><p><strong>Results: </strong>360 patients diagnosed with OHT were recruited with a mean age of 69 years. In the DCE, reducing the risk of conversion to glaucoma was the most important factor influencing respondents' choice of monitoring service. Respondents preferred hospital-based monitoring services to community optometrist monitoring, and annual monitoring compared with more frequent (every 6 months) and less frequent (every 18 or 24 months) monitoring. These results can be monetised using WTP. Results of heterogeneity analysis suggest that patients with prior experience in community optometrist monitoring preferred this to hospital-based monitoring.</p><p><strong>Conclusions: </strong>Although hospital-based monitoring is generally preferred, patients with prior experience in community services have a different opinion, suggesting that patients who are unfamiliar with community optometry services may need additional support to accept monitoring in this setting.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603805/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458532","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}

{"title":"Increased choroidal stromal area in patients with active Graves' ophthalmopathy based on binarisation method of optical coherence tomographic images.","authors":"Min Zhou, Dide Wu, Leqi Cai, Congyao Wang, Yihua Su, Ye Li, Wanyi Ke, Tingting Chen, Shubin Hong, Haipeng Xiao, Pengxia Wan","doi":"10.1136/bmjophth-2023-001443","DOIUrl":"https://doi.org/10.1136/bmjophth-2023-001443","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the change in choroidal components of patients with Graves' ophthalmopathy (GO) with different degrees of disease activity and severity by using the image binarisation method of optical coherence tomography (OCT).</p><p><strong>Methods: </strong>This cross-sectional study included 151 eyes of 90 patients with GO. Patients were grouped according to the clinical activity score (CAS) and disease severity. Total choroidal area (TCA), luminal area, stromal area (SA) and choroidal vascularity index (CVI) were acquired by image binarisation of the OCT. Ocular parameters between groups were compared using generalised estimating equations, accounting for intereye correlation and adjusting for relevant factors.</p><p><strong>Results: </strong>As for the included eyes, 104 eyes were inactive GO and 47 eyes were active GO. Local choroidal thicknesses were thicker in active GO than in inactive GO. TCA and SA were significantly larger in active GO than in inactive GO group (3.44±0.91 mm² vs 3.14±0.88 mm², p=0.046; 1.16 (1.03-1.50) mm² vs 1.10 (0.96-1.27) mm², p=0.002, respectively). CAS was positively correlated with TCA (r=0.171, p=0.036) and SA (r=0.172, p=0.035), and negatively associated with CVI (r=-0.174, p=0.032). In multiple regression models, age, diopter and intraocular pressure (IOP) exhibited significant correlations with the SA (β=-0.006, p=0.010; β=0.076, p<0.001; β=0.015, p=0.010, respectively).</p><p><strong>Conclusions: </strong>Thickened choroid was observed in active GO compared with inactive GO. The proportional increase of SA was augmented as the disease activity progressed. Age, diopter and IOP were independent factors that affected choroidal area and components in patients with GO. Multicentre prospective cohort studies with a large sample size are still needed.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11481105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458518","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}

{"title":"Control of myopia using diffusion optics spectacle lenses: 4-year results of a multicentre randomised controlled, efficacy and safety study (CYPRESS).","authors":"Deborah Laughton, Jennifer S Hill, Marcella McParland, Vanessa Tasso, Jill Woods, Xiaoying Zhu, Graeme Young, Ruth Craven, Chris Hunt, Jay Neitz, Maureen Neitz, Thomas W Chalberg, Deborah Jones, James S Wolffsohn","doi":"10.1136/bmjophth-2024-001790","DOIUrl":"https://doi.org/10.1136/bmjophth-2024-001790","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate the myopia control efficacy of Diffusion Optics Technology (DOT) spectacle lenses in children over a 4-year treatment period.</p><p><strong>Methods: </strong>CYPRESS Part 1 (NCT03623074) was a 3-year multicentre, randomised, controlled, double-masked trial comparing two investigational spectacle lens DOT designs (Test 1, Test 2) and standard single vision Control lenses in 256 North American children aged 6-10 years. Children completing Part 1 (n=200) were invited to enrol in CYPRESS Part 2 (NCT04947735) for an additional 1-year period. In Part 2, Test 1 (n=35) and Control groups (n=42) continued with their original lens assignment and the Test 2 group (n=21) were crossed over to Test 1 (DOT 0.2) lenses. The co-primary endpoints were change from baseline in axial length (AL) and cycloplegic spherical equivalent refraction (cSER).</p><p><strong>Results: </strong>Test 1 spectacle lenses demonstrated superiority to the Control in both co-primary endpoints: with a difference between means (Test 1-Control) of -0.13 mm for AL (p=0.018) and 0.33 D for cSER (p=0.008) in Part 1 and -0.05 mm for AL (p=0.038) and 0.13 D for cSER (p=0.043) in Part 2. Comparing treatment effects in Part 1 and 2 suggests that COVID-19 public health restrictions negatively impacted treatment efficacy in study years 2 and 3.</p><p><strong>Conclusion: </strong>DOT 0.2 spectacle lenses are safe and effective at reducing myopia progression, with additional benefit evident in year 4 of wear. These results support the hypothesis that a mild reduction in retinal contrast can slow myopia progression in young children. The unprecedented disruption in participant schooling and lifestyle during the COVID-19 pandemic may have depressed treatment efficacy in Part 1.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of 100% autologous platelet-rich plasma and 100% autologous serum in dry eye disease: a randomised controlled trial.","authors":"Passara Jongkhajornpong, Kaevalin Lekhanont, Sasivimol Rattanasiri, Pawin Numthavaj, Gareth McKay, John Attia, Ammarin Thakkinstian","doi":"10.1136/bmjophth-2024-001857","DOIUrl":"10.1136/bmjophth-2024-001857","url":null,"abstract":"<p><strong>Objective: </strong>The 0bjective is to compare treatment effects between undiluted autologous platelet-rich plasma (APRP) and autologous serum (AS) in patients with moderate-to-severe dry eye disease (DED).</p><p><strong>Methods and analysis: </strong>A single-centre, randomised, double-masked, non-inferiority clinical trial was conducted. 96 adult DED patients with an Ocular Surface Disease Index (OSDI) Score of ≥23 and/or Oxford staining grade of ≥2 were randomised to receive either 100% APRP (n=48) or 100% AS (n=48) for 4 weeks. Primary outcomes included OSDI Score and ocular surface staining measured by Oxford grading scale at 4 weeks. Secondary outcomes included fluorescein tear break-up time, Schirmer's test, meibum quality and expressibility, and adverse events. The 95% CI for the mean difference in OSDI scores between groups was estimated to assess non-inferiority of the OSDI score at a prespecified margin of 4.18 points.</p><p><strong>Results: </strong>At week 4, there was no significant difference in decreased OSDI scores between groups, with the mean difference (100% APRP-100% AS) of 1.41 (95% CI -1.26, 4.08, p=0.299). The upper limit was less than the prespecified margin, indicating non-inferiority of 100% APRP vs 100% AS. The probabilities of achieving an Oxford grade 0-1 after treatment were not significantly different between groups, with an OR of 0.61 (95% CI 0.25, 1.52, p=0.288). No significant differences in secondary outcomes were observed between groups.</p><p><strong>Conclusion: </strong>In the short-term, 100% APRP was not inferior to 100% AS in reducing dry eye symptoms and ocular surface staining in moderate-to-severe DED.</p><p><strong>Trial registration number: </strong>NCT04683796.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388191","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}

{"title":"Segmentation and multiparametric evaluation of corneal whorl-like nerves for in vivo confocal microscopy images in dry eye disease.","authors":"Kang Yu, Yupei Chen, Ziqing Feng, Gengyuan Wang, Yuqing Deng, Jiaxiong Li, Lirong Ling, Ruiwen Xu, Peng Xiao, Jin Yuan","doi":"10.1136/bmjophth-2024-001861","DOIUrl":"https://doi.org/10.1136/bmjophth-2024-001861","url":null,"abstract":"<p><strong>Objective: </strong>To establish an automated corneal nerve analysis system for corneal in vivo confocal microscopy (IVCM) images from both the whorl-like corneal nerves in the inferior whorl (IW) region and the straight ones in the central cornea and to characterise the geometric features of cornea nerves in dry eye disease (DED).</p><p><strong>Methods and analysis: </strong>An encoder-decoder-based semi-supervised method was proposed for corneal nerve segmentation. This model's performance was compared with the ground truth provided by experienced clinicians, using Dice similarity coefficient (DSC), mean intersection over union (mIoU), accuracy (Acc), sensitivity (Sen) and specificity (Spe). The corneal nerve total length (CNFL), tortuosity (CNTor), fractal dimension (CND_f) and number of branching points (CNBP) were used for further analysis in an independent DED dataset including 50 patients with DED and 30 healthy controls.</p><p><strong>Results: </strong>The model achieved 95.72% Acc, 97.88% Spe, 80.61% Sen, 75.26% DSC, 77.57% mIoU and an area under the curve value of 0.98. For clinical evaluation, the CNFL, CNBP and CND_f for whorl-like and straight nerves showed a significant decrease in DED patients compared with healthy controls (p<0.05). Additionally, significantly elevated CNTor was detected in the IW in DED patients (p<0.05). The CNTor for straight corneal nerves, however, showed no significant alteration in DED patients (p>0.05).</p><p><strong>Conclusion: </strong>The proposed method segments both whorl-like and straight corneal nerves in IVCM images with high accuracy and offered parameters to objectively quantify DED-induced corneal nerve injury. The IW is an effective region to detect alterations of multiple geometric indices in DED patients.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388192","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}

{"title":"Comparative outcomes of selective laser trabeculoplasty delivered by optometrists compared with ophthalmologists: a UK-based multicentre observational study.","authors":"Chan Ning Lee, Alexander Delaney, Jay A L Richardson, Graham Freeman, Patrick J G Gunn, Stephen Harthan, Vincent Dubois, Kenneth Yau, Christopher Hemmerdinger, Robert Harper, Neeru A Vallabh","doi":"10.1136/bmjophth-2024-001870","DOIUrl":"10.1136/bmjophth-2024-001870","url":null,"abstract":"<p><strong>Background: </strong>Selective laser trabeculoplasty (SLT), a National Institute for Care and Health Excellence recommended first-line treatment for open-angle glaucoma and ocular hypertension, is increasingly delivered by optometrists. This retrospective multicentre observational study evaluates real-world outcomes of SLT comparing optometrist-treated to ophthalmologist-treated eyes.</p><p><strong>Methods: </strong>Adults aged ≥40 years receiving first SLT treatment at three UK hospital eye units (Aintree, Manchester, Macclesfield) between 1 August 2018 and 1 August 2021 were analysed using anonymised local audit data. Outcomes included intraocular pressure (IOP), visual acuity (VA), drop burden, complications including post-SLT IOP spikes, and composite treatment failures including repeat laser or glaucoma surgery, evaluated at 6-monthly intervals up to 24 months. Groups were compared with parametric and non-parametric tests, accounting for intereye correlation, and Kaplan-Meier survival analysis using composite treatment failure endpoints was conducted.</p><p><strong>Results: </strong>207 eyes (131 patients) were analysed, 84 (56 patients) optometrist-treated eyes compared with 123 ophthalmologist-treated eyes (75 patients). No statistically significant differences (p>0.05) were found in change in VA, IOP or glaucoma drops from pre-SLT baseline between optometrist and ophthalmologist-treated eyes, at all time points. More cataracts were detected in optometrist-treated eyes, however, this did not affect differences in VA or cataract surgery frequency. More optometrist-treated eyes underwent glaucoma surgery, however, ophthalmologist-treated eyes had higher drop burden and chance of composite treatment failure up to month 18.</p><p><strong>Conclusion: </strong>Outcomes of SLT treatment by optometrists and ophthalmologists are comparable up to 24 months post-treatment. Ophthalmologist-treated eyes may have had more aggressive eye-drop treatment, preventing the need for surgery.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11448136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364483","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}

{"title":"Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy.","authors":"Charles C Lin, Winston Chamberlain, Beth Ann Benetz, William Gensheimer, Jennifer Y Li, Bennie H Jeng, Jameson Clover, Nicole Varnado, Sarah Abdelrahman, Amrita Srinivasan, Zeba A Syed, Ellen H Koo, Benjamin F Arnold, Thomas M Lietman, Jonathan Lass, Jennifer Rose-Nussbaumer","doi":"10.1136/bmjophth-2024-001725","DOIUrl":"10.1136/bmjophth-2024-001725","url":null,"abstract":"<p><strong>Introduction: </strong>It remains uncertain whether Descemet membrane endothelial keratoplasty (DMEK) or Descemet stripping only (DSO) yields better outcomes in patients with symptomatic Fuchs endothelial corneal dystrophy (FECD). This paper presents the protocol for the Descemet Endothelial Thickness Comparison Trial II (DETECT II), a multicentre, outcome-masked, randomised, placebo-controlled, clinical trial comparing DMEK to DSO with ripasudil (DSO-R) for this patient population.</p><p><strong>Methods and analysis: </strong>A total of 60 patients with endothelial dysfunction due to symptomatic FECD will be enrolled from seven participating sites in the USA. The patients will be randomly assigned in a 1:1 ratio to one of the following treatment groups: group 1-DMEK plus topical placebo and group 2-DSO plus topical ripasudil 0.4%. The enrolment period is 24 months. The primary outcome is best spectacle-corrected visual acuity at 12 months. Secondary outcomes include peripheral and central endothelial cell density, visual acuity, vision-related quality of life and Pentacam Scheimpflug tomography. Study outcomes will be analysed using mixed effects linear regression. Adverse events, including rebubble procedures, endothelial failure and graft rejection, will be documented and analysed using appropriate statistical methods. DETECT II aims to provide evidence on the comparative effectiveness of DMEK and DSO-R. The results of this trial will contribute to optimising the treatment of FECD, while also exploring the cost-effectiveness of these interventions. Dissemination of findings through peer-reviewed publications and national/international meetings will facilitate knowledge translation and guide clinical practice in the field of corneal transplantation.</p><p><strong>Ethics and dissemination: </strong>A data and safety monitoring committee has been empanelled by the National Eye Institute. All study protocols will be subject to review and approval by WCG IRB as the single IRB of record. This study will comply with the National Institute of Health (NIH) Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. Data from the trial will be made available on reasonable request.</p><p><strong>Trial registration number: </strong>NCT05275972.</p>","PeriodicalId":9286,"journal":{"name":"BMJ Open Ophthalmology","volume":"9 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364484","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}