BMJ Open Ophthalmology最新文献

Purpose: The Clinical Activity Score (CAS) is widely used to assess thyroid eye disease (TED) activity but can vary based on the evaluator's expertise. We developed and externally validated Glandy CAS, a machine learning (ML)-assisted system for detecting active TED (CAS ≥3) using digital facial images. This clinical trial aimed to gain approval from the Korea Ministry of Food and Drug Safety (KMFDS) for this Software as a Medical Device (SaMD).

Methods: This is a clinical trial based on the retrospective cohort. Glandy CAS analysed 756 photos of patients with TED, classifying them as having active or inactive TED. Its diagnostic performance was compared with that of three general ophthalmologists (less than 5 years of experience), using the F1 score. The reference CAS was determined by an oculoplastic specialist.

Results: Active TED was detected in 207 of 756 patients. Glandy CAS achieved a sensitivity of 87.9%, specificity of 95.8% and an F1 score of 0.88. In comparison, general ophthalmologists had a sensitivity of 60.4%, specificity of 83.0% and an F1 score of 0.57. Glandy CAS predicted CAS within 1 point of the reference score in 82.3% of cases, with a mean absolute error of 0.83.

Conclusions: Glandy CAS, an ML-assisted system for detecting active TED using facial images, showed high accuracy and outperformed general ophthalmologists. This system can consistently and accurately assess disease activity, facilitating early detection and timely treatment of active TED. Based on this clinical trial, the SaMD received KMFDS approval (Product Licence No., 24-93).

Background: Few studies have assessed the impact of metformin use on glaucoma risk. The purpose of this study was to examine the association between metformin use and the incidence of primary open-angle glaucoma (POAG) in a diverse and large nationwide cohort.

Methods: We included a retrospective cohort study of 18 440 participants in the National Institutes of Health All of Us Research Program aged 40 years or older, with a diagnosis of diabetes mellitus and without a diagnosis of POAG prior to diabetes diagnosis or metformin use. Bivariate logistic regression, multivariable logistic regression and survival analysis were used to analyse the association between ever use of metformin and incidence of POAG.

Results: Within the cohort, 240 participants acquired a diagnosis of POAG during all available follow-up time, while 18 200 did not. In regression-based bivariate analysis, metformin use was significantly associated with a lower odds of developing POAG (OR 0.35, 95% CI 0.26 to 0.47, p<0.001). In multivariable regression analysis, metformin remained protective against POAG (OR 0.33, 95% CI 0.21 to 0.50, p<0.001), while the use of other diabetic medications was associated with an increased odds of developing POAG (OR 2.39, 95% CI 1.48 to 3.90, p<0.001). In survival analysis, the probability of developing POAG was significantly lower for the participants using metformin than for the participants not using metformin (log-rank p<0.001, Cox proportional HR 0.38, 95% CI 0.29 to 0.51).

Conclusions: This study provides additional large-scale observational health data supporting the protective role of metformin in the development of POAG. However, limitations include the study's observational design and lack of data on metformin dosage and duration, glaucoma severity and ocular exam findings. Despite these limitations, our findings contribute to the growing body of evidence suggesting a potential protective effect of metformin against POAG.

Background/aims: Recently, modified monofocal intraocular lenses (IOLs) (proposed mono plus IOLs) have emerged claiming to provide monofocal quality distance vision while enhancing intermediate distance visual performance. The purpose of this study was to conduct a literature review and compare the range of vision following cataract surgery with the implantation of standard monofocal, claimed monofocal plus and extended depth of focus (EDoF) IOLs.

Methods: Literature searches and a meta-analysis were conducted on Embase, PubMed, IOLEvidence App and the Food and Drug Administration premarket approval database. Mean defocus curves were calculated with a random effect model and study quality was assessed.

Results: After eliminating duplicate publications, 36 studies were included in the data extraction process. Standard monofocal IOLs were implanted in 549 eyes, 360 eyes with claimed mono plus IOLs and 1898 eyes with EDoF IOLs. At far viewing acuity, the performance of all three lens categories appeared comparable: all p>0.05. However, at the intermediate distance of 66 cm (-1.5D), and at a near distance of 40 cm (-2.50D), monofocal and mono plus defocus curve acuities exhibited comparable performance: p=0.22 and 0.77 respectively, while EDoF lenses demonstrated better acuity (all p<0.05).

Conclusions: There is a lack of standardisation of defocus curve measurements among published papers included in this meta-analysis. Despite some slight inconsistencies in measurements, the range of vision of standard monofocal IOLs and mono plus IOLs as measured by the defocus curve appears to be similar. The EDoF IOLs in this meta-analysis indicate a potentially better range of vision compared with mono plus and monofocal IOLs.

Synopsis: This meta-analysis seems to indicate that EDoF IOLs may have a better range of vision as measured by defocus curves compared with mono plus and monofocal IOLs.

Objective: This study aimed to assess the effectiveness of verbal counselling and varenicline in achieving smoking cessation among patients with thyroid eye disease (TED) and to identify predictive factors associated with successful smoking cessation.

Methods and analysis: A cross-sectional analysis of data from the Iran TED (IrTED) Registry was conducted. Patients' demographics and TED severity/activity were recorded. As a routine at the TED clinic in Rassoul Akram Hospital, since 2020, all smoking patients have undergone smoking cessation verbal counselling in the first and almost every subsequent visit session. The effectiveness of verbal counselling was assessed through a telephone survey. Retrospectively, the association between successful smoking cessation and disease severity/activity was evaluated. Prospectively, patients who failed or refused to quit smoking after counselling were offered varenicline. Acceptance, compliance and adherence rates were determined.

Results: While 379/685 patients of the IrTED 2013-2023 database (55.32%) reported no tobacco exposure, the remaining were active (n=117, 17.08%), passive (n=134, 19.56%) and former smokers (n=55, 8.02%). In 2020-2023, 73 active tobacco-smoking patients with TED were enrolled, all of whom received verbal cessation counselling at their first and subsequent visits. On the follow-up phone call, 51/73 were contacted, and 25/51 (49.01%) reported successful smoking cessation after verbal counselling. The remaining 26/51 smokers were offered varenicline (on the phone call); however, only 7/26 (26.92%) attended the prescription session. Of these patients, 3/7 (42.85%) completed the first month of treatment, and just 1/3 (33.33%) finished the 3-month course, successfully quitting smoking until the final follow-up (18 months). One patient (14.28%) reported constipation, and another one reported sleep paralysis (14.28%) as an adverse event.

Conclusion: Verbal counselling demonstrates effectiveness in smoking cessation for patients with TED, with nearly half of smokers successfully quitting the habit. Among those who failed to quit after verbal counselling, varenicline showed limited effectiveness, indicating poor compliance and motivation deficit.

Objectives: This study aims to detect characteristic fundus changes in pathological myopia using deep learning (DL)-based analysis of ultra-widefield (UWF) fundus imaging.

Methods: Following the exclusion of low-quality images, this cross-sectional study used 1105 UWF images from 543 patients with high myopia to develop the model, along with 293 images from 150 patients with high myopia for external testing. All images were retrospectively collected from patients with high myopia at Shanghai General Hospital and Shanghai Eye Diseases Prevention and Treatment Center between 2018 and 2024. We trained a DL model based on an ophthalmology foundational model to detect myopic maculopathy (MM) and posterior staphyloma (PS).

Results: The proposed RETFound-enhanced model demonstrated robust performance. For five-category classification of MM, it achieved 65.4% accuracy and an F1 score of 0.648, outperforming other methods. In three-category MM classification, it achieved 79.4% accuracy and an F1 score of 0.793. For PS detection, the model reached 84.1% accuracy, an F1 score of 0.814 and an area under the receiver operating characteristic curve (AUROC) of 0.886, highlighting its effectiveness as a screening tool. External validation showed consistent performance, with 64.4% accuracy for five-category MM classification, 79.8% accuracy for three-category classification and 81.2% accuracy for PS, confirming robustness across cohorts.

Conclusions: This study presents an effective diagnostic model for pathological myopia using UWF fundus imaging and a foundation model. The integration of DL with non-mydriatic UWF fundus imaging demonstrates promising potential for applications in primary healthcare, particularly in underserved areas, enabling accessible screening for high myopia-related fundus changes.

Purpose: To investigate the imaging quality, efficiency and satisfaction of fully self-service fundus photography compared with traditional fundus photography performed by experienced operators among middle-aged individuals.

Methods: Participants aged 45-64 in the community of Shanghai were included, and eye disease screenings were carried out after obtaining informed consent. All participants had no cataracts or other conditions that could potentially compromise the quality of fundus imaging. Participants voluntarily chose the fully self-service fundus photography group or the traditional fundus photography group. A statistical analysis was performed to analyse the imaging quality, efficiency and satisfaction of self-service fundus photography.

Results: We included 457 individuals with an average age of 56.93 years. Fully self-service fundus photography produces similar imaging quality to manual examinations. Additionally, this photography significantly increases residents' willingness to undergo eye disease screening again, particularly among those with better visual acuity, compared with traditional doctor-led screenings.

Conclusions: This study confirms the reliability of fully self-service fundus photography, and its ability to enhance compliance and willingness for follow-up screenings among individuals aged 45-64. Promoting fully self-service fundus photography is beneficial for screening blinding eye diseases in the middle-aged population. Given the limited geographical scope and age range of this study, larger multicentre studies are needed to confirm the broader applicability of fully self-service fundus photography and to establish effective screening models for high-risk occupational populations.

Background: Data on long-term outcomes of antivascular endothelial growth factor therapy in retinopathy of prematurity (ROP) are still rare. We present 5-year post-treatment ophthalmological and paediatric outcomes of the prospective, multicentre, randomised, double-blinded, controlled pilot study CARE-ROP (Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity).

Methods: 14 patients (28 eyes) completed the ophthalmologic and 5 patients completed the paediatric 5-year follow-up assessment. The ophthalmological assessment included best-corrected visual acuity (BCVA), orthoptic status, slit lamp examination, intraocular pressure and funduscopy. The paediatric examination followed the German Neonatal Network protocol and covered cognitive, motor and sensory development.

Results: 17 of 28 eyes exhibited at least one ocular abnormality, such as optic disc pallor or atrophy of the optic nerve head, retinal pigment epithelium (RPE) pigment changes, persistent tortuosity or macular hypoplasia. Despite this, 19 of 26 eyes demonstrated a logarithm of the Minimum Angle of Resolution (logMAR) BCVA of 0.3 or better. Mean refractive error was -0.9 D (±3.4 D) with only two eyes of one infant having high myopia of < -5 D. The neurodevelopmental results were within the expected range for a population of preterm infants with treatment-warranting ROP but need to be interpreted with caution due to the low number of five patients.

Conclusion: The 5-year ophthalmologic and paediatric outcomes of the CARE-ROP study confirm the previous results and add important additional information on long-term safety of 0.12 and 0.20 mg ranibizumab for the treatment of ROP. The ophthalmologic functional outcome regarding BCVA and refraction is promising. These exploratory long-term data, however, need to be interpreted with caution due to the low patient number both in the ophthalmologic and paediatric assessment.

Introduction: Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss among people over 55 years of age globally, being neovascular AMD (nAMD) its most aggressive form. Its treatment consists of the use of drugs that block vascular endothelial growth factor (anti-VEGF). Proteomics may allow the identification of differentially expressed proteins between responders and non-responders to each anti-VEGF drug. Thus, the objective of Pharmacoproteomics in the development of personalised medicine in Age-related Macular Degeneration (PHARPRO-AMD) is to find new proteomic biomarkers, predictive of response to antiangiogenic treatment in patients with nAMD.

Methods and analysis: PHARPRO-AMD is a nationwide, multicentre, prospective, observational study. Treatment-naïve patients with nAMD starting anti-VEGF therapy will be enrolled and followed up for 2 years. During this period, clinical variables will be gathered to classify treatment response. In addition, blood, tear and vitreous and aqueous humour samples will be collected and will undergo a ZenoSWATH proteomic analysis. Relevant biomarkers identified and response classification will be used to perform a multivariate logistic regression and construct receiver operating characteristic curves.

Results: The study is expected to identify a panel of proteomic biomarkers predictive of anti-VEGF treatment response. Integrating data from invasive and non-invasive biological samples may enhance clinical applicability. Once validated, these biomarkers could support the design of future clinical trials on biomarker-guided therapies, helping to optimise treatment regimens and improve visual outcomes.

Conclusions: The PHARPRO-AMD study aims to provide proof-of-concept for biomarker-guided anti-VEGF therapy in nAMD, potentially improving vision outcomes. A notable limitation is the exclusion of patients with visual acuity above 73 Early Treatment of Diabetic Retinopathy Study letters, a criterion chosen to reduce potential ceiling effects and improve response assessment accuracy.

Ethics and dissemination: Approved by the Galician Network of Ethics Committees, with nationwide validity. Anonymised data will be deposited in open-access repositories and published in peer-reviewed journals.

Trial registration number: Spanish Clinical Studies Registry (REec) (0033-2024-OBS).

Background/aims: Glaucoma is among the leading causes of permanent visual impairment, with its prevalence increasing due to population ageing. This study aimed to evaluate the accuracy of the 2004 system dynamics (SD) model predicting the number of glaucoma medication reimbursees in Finland until 2023, update the model using 1990-2023 data to forecast medication users until 2070 and assess whether the observed deceleration in net growth during 2015-2023 represented a temporary or sustained trend.

Methods: Data on reimbursed glaucoma medication users (1986-2023) were sourced from the Finnish Social Insurance Institution, alongside Finnish population projections (2021-2070). An updated SD model was developed using historical data, stratified by age groups, and incorporating demographic shifts, mortality and migration. Predictions were validated against observed trends and parameterised using expert consensus and literature estimates.

Results: By 2070 in Finland, the updated model predicts a 57% increase in glaucoma medication reimbursees (151 846 individuals; 28 per 1000 inhabitants), primarily driven by growth in ≥75-year-old population. The updated model captured the slowdown in net growth of reimbursees in 2015-2023. A similar slowdown is projected to reoccur during 2033-2048, again followed by an acceleration in growth.

Conclusions: The demand for glaucoma care in Finland will increase by 2070, necessitating proactive resource allocation and continuous monitoring using real-world data to ensure optimal care delivery. Temporary changes in the demand for glaucoma care underscore the need for adaptive forecasting methods. The updated model provides a framework for monitoring trends and informing resource allocation in national eye care systems.

Objective: To investigate the causal link between ametropia and diabetic retinopathy, as well as to offer genetic support for the association between these two conditions.

Methods: This study employed a methodology involving the utilisation of genome-wide association studies data that are publicly accessible. Specifically, single nucleotide polymorphisms (SNPs) that exhibit a strong association with ametropia were employed as instrumental variables, and a two-sample Mendelian randomization (MR) approach was employed to examine the causal relationship between different types of ametropia and diabetic retinopathy. The main findings were derived from the utilisation of inverse variance weighted (IVW), while supplementary results were obtained through the utilisation of MR Egger, weighted median, simple mode and weighted mode. Additionally, a sensitivity analysis was conducted using the 'leave-one-out' method. Cochran's Q statistics were also used to quantify the heterogeneity of SNPs.

Results: 38 SNPs were finally included. The results of the IVW analysis indicate that myopia may exert an inhibitory effect on the development of diabetic retinopathy (OR=0.596, 95% CI (0.371, 0.957), p<0.05). Conversely, hypermetropia (OR=8.882, 95% CI (0.389×10^-3, 2.06×10⁵), p>0.05) and astigmatism (OR=1.004, 95% CI (0.888, 1.135), p>0.05) do not exhibit a causal relationship with the risk of diabetic retinopathy.

Conclusion: This two-sample Mendelian randomization study provides evidence that myopia may impede diabetic retinopathy occurrence, while hypermetropia and astigmatism show no significant causal effects. However, our analysis treats refractive errors as independent entities, which may not reflect their clinical interdependence. Further investigations are warranted to elucidate myopia's protective mechanisms.