Acta Ophthalmologica最新文献

Objective: To assess the adherence of glaucoma surgical and laser studies to WGA guidelines for reporting glaucoma surgery studies, analyse trends in adherence over time and explore associations between adherence and study characteristics.

Methods: Systematic review (PROSPERO:CRD42023394477) of glaucoma surgical and laser studies published between 2010 and 2023 in PubMed/MEDLINE and EMBASE. Eligible studies included RCTs, non-randomized comparative and prospective observational designs (>100 eyes). Two reviewers independently extracted data across five domains: Methodology, Definition of success, Ethics, Postoperative complications and Statistical reporting. Temporal trends and associations with study features were analysed using linear regression.

Results: Two hundred and fifty-six studies were included, 75% of which were published in Q1-Q3 journals. Mean overall adherence was 47% ± 9.2%. Domain-level adherence was highest in Ethics (61% ± 20%), followed by Postoperative complications (50% ± 22%), Statistical reporting (48% ± 18%), Methodology (44% ± 12%) and Definition of success (30% ± 13%). No significant differences (p > 0.06) were observed in overall adherence for studies from Europe, Asia, Oceania or the Middle East. Studies involving cataract surgery for angle-closure disease (est. = -10% [-19%, -2.2%], p = 0.014) and laser trabeculoplasty (est. = -7.1% [-11%, -3.5%], p < 0.001) had lower adherence compared with trabeculectomy, while MIGS studies showed no difference (p = 0.45). Visual field progression was reported in only 3% of studies, while various anatomical outcomes (e.g. bleb morphology) were reported in 0%-24% of studies.

Conclusion: Current literature shows poor adherence to WGA guidelines across both traditional and newer glaucoma surgeries, reflecting inadequate reporting and outdated recommendations. Evidence-based updates, broader consensus and stronger implementation are needed to ensure standardized and meaningful reporting.

Purpose: Norwegian guidelines designate off-label Avastin as the first-line intravitreal therapy for neovascular age-related macular degeneration (nAMD) because of its well-documented clinical efficacy and low price. However, this overlooks non-drug costs, which increase with injection frequency. We evaluated whether newer, longer-acting agents offer greater long-term cost-efficiency by reducing total costs despite higher drug prices in a Norwegian setting.

Methods: We developed a 2-year cost-minimization model that included pharmaceutical, consultation and administrative and patient-related costs in Norway; the pharmaceutical cost component incorporated the routine practice of splitting vials into prefilled syringes in hospital pharmacies. The model compared four nAMD monotherapies, Avastin, Eylea 2 mg, Eylea 8 mg and Vabysmo, as well as the common practice of switching treatment-resistant patients from Avastin to Eylea 2 mg. We derived injection frequencies from clinical trials (for monotherapies) or observational data (for switching) and conducted one-way sensitivity analyses to identify key cost drivers.

Results: Over 2 years, the switching regimen had the highest per-patient cost (146 722 NOK), followed by Eylea 2 mg (100 481 NOK), Vabysmo (93 207 NOK), Avastin (86 262 NOK) and Eylea 8 mg (68 738 NOK). Avastin had the lowest drug cost, but its high injection frequency increased non-drug costs. Sensitivity analyses showed that injection frequency strongly influenced total costs for high-priced drugs, while patient time had a substantial impact for Avastin.

Conclusion: In our model, longer-acting agents reduced injection frequency and decreased overall treatment costs. These findings suggest that adopting longer-acting monotherapy could improve cost-efficiency in long-term nAMD management in Norway.

Purpose: To assess the validity of the HelpMeSee Manual Small Incision Cataract Surgery (MSICS) module as a virtual reality training tool for technical skills and stress management in ophthalmology.

Methods: This prospective study enrolled 47 volunteer surgeons from five groups: four groups of eye surgeons with increasing experience (novice, junior, senior and expert) and a fifth group of experts from other specialties. Participants completed two standardized MSICS training runs on the HelpMeSee simulator. Performance scores, penalties and completion time were recorded. Ergonomics were assessed via the Rapid Upper Limb Assessment (RULA) score, and stress was evaluated subjectively and objectively using the State-Trait Anxiety Inventory-Y (STAI-Y) and the Analgesia Nociception Index (ANI) score. Data from the two runs were analysed and compared across groups.

Results: Overall scores increased significantly from novice residents (32.4 ± 10.7 out of 72) to the expert ophthalmic surgeons (50.1 ± 9.41) (p < 0.001). Non-ophthalmic experts had a lower mean score (16.8 ± 18.0). Total penalties, particularly in the second run, decreased with experience among eye surgeons, while experts from other specialties incurred the highest penalties. Time analysis did not differ between groups, as for RULA or STAI-Y scores. The mean ANI score decreased with experience, suggesting higher stress levels in more experienced participants.

Conclusions: The HelpMeSee MSICS module effectively differentiates surgical experience levels, confirming its validity as a tool for technical skills training. The ANI score demonstrated modified behaviour in expert surgeons, suggesting the simulator's potential for assessing non-technical skills. These findings support the use of this virtual reality simulator for objective, skills-based surgical education.

Conventional optical coherence tomography (OCT) has a floor effect in patients with severe visual field loss, such as seen in advanced primary open-angle glaucoma (POAG). OCT angiography (OCTA) does not suffer from such a floor effect. However, which OCTA parameters are most useful for monitoring longitudinal progression is unclear. We conducted a systematic review and meta-analysis to investigate the clinical use of OCTA in monitoring the progression of intermediate and advanced POAG by searching four databases (Medline, Embase, Web of Science and Cochrane Database of Systematic Reviews) for longitudinal studies on POAG and OCTA. For each meta-analysed OCTA parameter, we calculated a pooled effect estimate with a 95% confidence interval (95% CI). Parameters that could not be meta-analysed were compared narratively. A total of 18 studies were included in the systematic review and seven in the meta-analyses. In the meta-analyses, a lower baseline peripapillary vessel density (VD) significantly increased the risk of visual field (VF) progression (HR [95% CI]: 1.05 [1.02, 1.07] for each percentage decrease in peripapillary VD per year). Baseline parafoveal VD and risk of VF progression showed no significant association. The inferior hemifield foveal avascular zone parameters and the presence of peripapillary choroidal microvascular dropout were significantly associated with the risk of VF progression in the systematic review. Peripapillary VD may be a useful predictor of VF progression in intermediate and advanced glaucoma patients. Although FAZ and MvD also seem to be potential predictors, longitudinal studies on advanced POAG are limited and heterogeneous, highlighting the need for more consistent and comprehensive research.

Purpose: To perform a head-to-head comparison of two extended range of field intraocular lenses (IOLs) for their patient-reported outcome measures.

Setting: Keye Eye Hospital, Seoul, Korea.

Design: Clinical cohort study.

Methods: Eighty-five emmetropic bilaterally operated patients (PureSee [N = 34] vs. AcrySof Vivity [N = 51]) were compared for their visual outcomes, dysphotopsia (scale 0-100), and spectacle-independent visual function index (VF)-14 questionnaire scores at the 6-month timepoint.

Results: Baseline patient and ophthalmic variables were comparable between the groups. Acrysof Vivity provided better uncorrected near (0.21 ± 0.10 vs. 0.28 ± 0.07 LogMAR units, p < 0.001) and intermediate visual acuities (0.08 ± 0.09 vs. 0.22 ± 0.08 LogMAR units, p < 0.001) compared with PureSee. In contrast, contrast sensitivities in photopic (1.57 ± 0.14 vs. 1.45 ± 0.17 LogCWeber, p = 0.024) and mesopic conditions (1.30 ± 0.12 vs. 1.19 ± 0.17 LogCWeber, p = 0.025) were greater for PureSee than Acrysof Vivity. PureSee was associated with overall mean dysphotopsia scores (1.3 ± 3.2 vs. 5.8 ± 9.3, p = 0.009) significantly less than for Acrysof Vivity. Spectacle-independent VF-14 scores for visual acuities at near, specifically reading small print (76.0 ± 20.0 vs. 65.9 ± 22.4, p = 0.046), newspaper or a book (94.8 ± 11.5 vs. 80.3 ± 19.5, p < 0.001), and large-print or numbers on a telephone (88.0 ± 15.4 vs. 79.5 ± 18.2, p = 0.030) were significantly greater for Acrysof Vivity than PureSee, whereas overall mean spectacle-independent VF-14 scores remained statistically non-significant for the two IOLs (92.6 ± 5.7 vs. 89.3 ± 9.7, respectively; p = 0.115).

Conclusions: Acrysof Vivity was associated with greater spectacle-independent near visual acuity and visual function for reading, while PureSee outperformed in photopic and mesopic contrast sensitivities, glare, starburst, and overall dysphotopsia. Based on these pros and cons, optimal extended range of field IOL selection should be aligned with the individual's needs and concerns.

Purpose: This study aimed to evaluate 5-year longitudinal changes in both central and peripheral corneal thickness and to explore associations with ocular characteristics as well as systemic cardiovascular risk factors (CVRF).

Methods: The Gutenberg Health Study is a prospective population-based cohort study comprising 15 010 participants aged 35-74 years at baseline. Scheimpflug tomography (Pentacam, Oculus, Wetzlar, Germany) was performed during both the 5-year (2012-2017) and 10-year (2017-2022) follow-up examinations. Longitudinal changes in central corneal thickness (CCT) and in concentric rings at 2 mm (D2), 4 mm (D4), 6 mm (D6), 8 mm (D8) and 10 mm (D10) were evaluated in eyes with available measurements at both time points. Additionally, associations between changes in CCT and ocular characteristics as well as systemic CVRFs at the 5-year FU as well as its 5-year changes (Δ) were investigated by multivariable linear regression analyses using generalized estimating equations.

Results: 8755 eyes of 4857 participants were included and a significant reduction in CCT was observed across all age groups over 5 years. Peripheral corneal thickness remained stable over time. Multivariable analyses identified associations with a change in CCT and ocular characteristics including corneal diameter (B = -0.06, p < 0.0001), axial length (B = 0.04, p < 0.008), pseudophakia at the 5-year examination (B = -0.18, p < 0.03) as well as systemic CVRF including age (B = -0.04, p < 0.008), HbA1c (B = 0.03; p < 0.040), ΔHbA1c (B = 0.05; p < 0.001), ΔLDL (B = -0.03, p < 0.047), ΔHDL (B = -0.05, p = 0.0006), ΔMAP (B = -0.04, p < 0.01) and a continuous smoking status (B = 0.08, p < 0.035).

Conclusion: While observing a 5-year decline in CCT, peripheral corneal thickness remained relatively stable. We observed longitudinal associations between CCT changes and HbA1c, lipid profile, mean arterial pressure and smoking, suggesting that corneal thickness changes may be influenced by cardiovascular and metabolic health and thus may be taken into consideration in glaucoma risk stratification.

Purpose: Mesopic microperimetry (mMP) is a promising functional endpoint in clinical trials for Stargardt disease type 1 (STGD1). This study evaluated the test-retest variability of mMP and influencing factors, which is essential for ensuring reliability in future STGD1 trials.

Methods: One hundred and fifteen eyes from 68 patients enrolled in the prospective, tertiary, multicentre STArgardt Remofuscin Treatment Trial (STARTT) underwent mMP testing using the macular integrity assessment (MAIA) microperimeter (CenterVue, Padova, Italy) at both the screening (first) and baseline (second) visits of the trial. Test-retest variability was assessed using Bland-Altman analyses and coefficients of repeatability (CoR). Retinal sensitivity metrics included mean sensitivity (MS) and pointwise sensitivity (PWS). Other factors including fixation stability, exam duration and learning effect were analysed.

Results: MS demonstrated the lowest variability (CoR: 3.53 dB, 95% CI: 3.07-3.99), while PWS exhibited the highest (CoR: 12.69 dB, 95% CI: 12.47-12.91). Variability decreased in sensitivity ranges from -1 to 3 dB and 16 to 32 dB and from central to peripheral regions. Test duration (Spearman's ρ = 0.609, p < 0.001) and fixation losses (Spearman's ρ = 0.284, p = 0.003) were significantly associated with increased variability. Other fixation stability metrics showed no correlation. No learning effect was observed.

Conclusions: Given its high variability, PWS should be used cautiously. MS offers lower variability but may mask localised functional changes. A parafoveal ring strategy may improve reliability but requires validation. Limiting test duration to ≤450 seconds and comprehensive operator training are recommended to minimise potential bias.

Aim: To evaluate the impact of initial mono- versus multitherapy on the ocular surface and related quality of life after 5 years follow-up in the Glaucoma Intensive Treatment Study (GITS).

Method: The study included patients with primary open-angle glaucoma and pseudoexfoliation glaucoma who completed 5-year follow-up in GITS. Assessment of ocular surface disease (OSD) symptoms was done using a Swedish Translation of the OSD Index (OSDI). Signs of OSD were assessed with tear break-up time (BUT), Schirmer I test and staining using Lissamine green. Rasch analysis was used to analyse OSDI results.

Results: Data on OSD symptoms were available at 5 years in 90% (219/242) of all participants initially included in GITS. Subjective or objective OSD findings did not differ significantly between mono- and multitherapy. More than 90% of patients in both arms reported no or little subjective ocular surface problems and showed no or minimal staining with Lissamine green at the 60-month visit. Furthermore, 46% had normal BUT and 60% normal Schirmer tests. Use of preservative-free drops or need for additive lubricating tear drops did not differ between the arms.

Conclusion: We found no differences in objective or subjective impact on ocular surface between the two randomization arms. However, a subgroup of glaucoma patients had more severe OSD irrespective of the amount of topical glaucoma treatment received, and this should be considered when choosing glaucoma therapy treatment in this subgroup by considering laser treatment or non-preserved eye drops.

Purpose: To investigate changes in choroidal and retinal thickness before and during myopia control treatment with orthokeratology lenses (OKL) in myopic children.

Methods: This was a sub-study of CONTROL and CONTROL2 studies. The present study was a 2-year, prospective, single-group interventional study consisting of a 6-month pre-treatment observation period followed by 18-month OKL treatment. Choroidal and retinal thicknesses were measured using a 3D macula scan with swept-source optical coherence tomography. All thickness measures were corrected for magnification using the Imagenet6 software. Axial length was measured using Lenstar LS900 and corrected for change in central corneal thickness. Data were collected at three pre-treatment visits and seven post-treatment visits (from Day 3 up to 18 months).

Results: The 20 study participants had a mean age of 11.2 ± 1.9 years, median cycloplegic spherical equivalent refractive error of -2.58 diopters (range - 4.75 to -1.00) and mean axial length of 24.56 ± 0.63 mm. During the pre-treatment period, there was a statistically significant decrease in retinal thickness of -1.44 μm (p = 0.038, SE 0.70, 95% CI -2.82 to -0.08), but a significant increase was seen after initiation of OKL treatment. Thickness peaked at 2.54 μm (p < 0.001, SE 0.72, 95% CI 1.13 to 3.95) at the 6-month follow-up. We observed a tendency for the choroidal thickness to decrease during the pre-treatment period (-5.96 μm, p = 0.12, SE 3.78, 95% CI -13.37 to 1.46) and then a statistically significant increase after treatment initiation with a peak of 11.95 μm after 1 month of treatment (p = 0.003, SE 4.08, 95% CI 3.94 to 19.96). Short-term change in choroidal thickness after treatment initiation did not correlate with change in overall eye length defined as subfoveal choroidal thickness plus axial length adjusted for post-treatment change in central corneal thickness. For each individual participant, the choroidal thickness and retinal thickness were highly positively correlated at each visit throughout the study (p < 0.001, 95% CI 0.69 to 2.09, linear mixed model).

Conclusion: Treatment with OKL increased both retinal and choroidal thickness in myopic children. Short-term change in choroidal thickness was not a predictor for growth of the overall eye length. Further studies of the presumed structural changes in the choroid and the retina are warranted.

Purpose: To evaluate changes in corneal tomography, pachymetry and endothelial cell density (ECD) following Paul Glaucoma Implant (PGI) surgery.

Methods: Seventy-three patients were prospectively examined. Repeated measures anova was used to analyse corneal tomography, corneal thickness and ECD at baseline, 6 and 12 months.

Results: PGI surgery was not associated with clinically meaningful changes in corneal tomography parameters. Simulated astigmatism and posterior astigmatism remained stable over 12 months. Simulated average keratometry showed a small but statistically significant flattening (≈0.3 diopters), whereas posterior average keratometry remained unchanged. Although some changes reached statistical significance, their magnitude was minimal and unlikely to be clinically relevant. Central corneal thickness remained stable, but pachymetry in the tube quadrant increased in the operated eyes, while adjusted pairwise comparisons were non-significant. Central ECD did not change significantly after surgery (p = 0.67). In contrast, paracentral (-2.9%) and peripheral (-4.7%) ECD values declined significantly over 12 months (p = 0.03 and p = 0.001, respectively) and study eyes consistently showed lower values than contralateral control eyes. However, PGI surgery did not accelerate the rate of cell loss, as the time × eye interaction was not significant.

Conclusions: PGI surgery did not induce progressive changes in corneal astigmatism or pachymetry during the first postoperative year. Central ECD remained stable, while paracentral and peripheral regions showed a moderate decline. PGI did not increase the rate of endothelial cell loss and the observed reduction was lower than previously reported for other glaucoma drainage implants.