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BackgroundPresentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients.AimTo compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG).Methods Design: A prospective, pragmatic multicentre randomised controlled trial (RCT).SettingTwenty-seven UK hospital eye services.ParticipantsFour hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss.InterventionParticipants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes).Main outcome measuresThe primary outcome is vision-related quality of life measured by the National Eye Institute—Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated.ResultsThe study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years.ConclusionsTreatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma.Trial registration numberISRCTN56878850, Pre-results.

To investigate the cost-effectiveness of implementing iStent inject trabecular bypass stent (TBS) in conjunction with cataract surgery (Cat Sx) in patients with mild-to-moderate glaucoma from a societal perspective in France. The secondary objective was to explore the economic impact of iStent inject TBS in patients who comply to different degrees with their anti-glaucoma medications. A previously published Markov model was adapted to estimate the cost-effectiveness of treatment with iStent inject TBS + Cat Sx versus Cat Sx alone over a lifetime time horizon in patients with mild-to-moderate open-angle glaucoma in France. Progression was modeled by health states reflecting increasing stages of vision loss. Disease progression was obtained from the two-year randomized clinical trial assessing safety and effectiveness of both interventions. French specific health-state utilities and costs were obtained through a targeted literature review. Model structure and inputs were validated by French ophthalmologists. Outcomes were expressed as incremental cost per quality-adjusted life-year (QALY) gained. The robustness of results was tested through sensitivity analyses. iStent inject TBS + Cat Sx reduced the number of medications needed and risk of blindness. Incremental cost and QALYs were €75 and 0.065 leading to an incremental cost-effectiveness ratio (ICER) of €1,154/QALY gained. ICER ranged from dominating for non-persistent patients to €31,127 patients fully persistent with their medication regime. Results from one-way sensitivity analysis had a maximum ICER of €29,000 when varying input parameters. iStent inject TBS + Cat Sx had an 86% chance of being cost-effective at a willingness-to-pay threshold of €30,000 per QALY gained. Results demonstrate that iStent inject TBS + Cat Sx is a cost-effective intervention for intraocular pressure reduction when compared to Cat Sx alone in France.

Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28–0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period. Pfizer, UK National Institute for Health Research Biomedical Research Centre.

BackgroundGlaucoma staging is critical for treatment planning but has rarely been tested in severe/end-stage disease. We compared the performance of the Disc Damage Likelihood Scale (DDLS) and cup:disc ratio (CDR) using a functional glaucoma staging system (GSS) as the reference standard.MethodsPost hoc analysis of a randomised controlled trial at the Eye Department of Kilimanjaro Christian Medical Centre, Tanzania. Eligible participants (aged ≥18 years) with open-angle glaucoma, intraocular pressure (IOP) of >21 mm Hg, were randomised to timolol 0.5% eye drops or selective laser trabeculoplasty. Fundoscopy established vertical and horizontal CDRs and DDLS. Visual acuity and static visual fields were graded (GSS). The study used area under the receiver operating characteristic (AROC) curves and Spearman’s rank correlation coefficients to compare staging systems. Logistic regression with generalised estimating equations determined risk factors of functional severe/end-stage glaucoma.Results382 eyes (201 participants) were evaluated; 195 (51%) had severe or end-stage glaucoma; mean IOP was 26.7 (SD 6.9) mm Hg. DDLS yielded an AROC of 0.90 (95% CI 0.87 to 0.93), vertical cup:disc ratio (vCDR) of 0.88 (95% CI 0.85 to 0.91, p=0.048) for identifying severe/end-stage disease. Correlation coefficients comparing GSS to DDLS and vCDRs were 0.73 and 0.71, respectively. Advanced structural stages, vision impairment, higher IOP and less financial resources were risk factors of functional severe/end-stage glaucoma.ConclusionThis study indicates that both structural staging systems can differentiate severe/end-stage glaucoma from less severe disease, with a moderate advantage of DDLS over CDR. Clinical examination of the optic disc plays an important role in addition to functional assessment when managing severe/end-stage glaucoma.

AbstractObjectiveTo determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.DesignPragmatic multicentre randomised controlled trial.Setting27 secondary care glaucoma departments in the UK.Participants453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.InterventionsMitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226)Main outcome measuresPrimary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months. Secondary outcomes: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.ResultsAt 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval −1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference −2.8 (−3.8 to −1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.ConclusionPrimary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.Trial registrationHealth Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.

Purpose To assess the efficacy of adding Ahmed’s sub-flap mattress suture to deep sclerectomy (DS). Methods Forty eyes with open angle glaucoma were assigned randomly into two groups: Group A : underwent DS with Ahmed’s sub-flap mattress suture. Group B : underwent conventional DS. Patients were followed up closely for 6 months with serial IOP measurements and ultrasound biomicroscopy (UBM) was used to assess the surgical site functionally and anatomically at the first and sixth month. Results Adding Ahmed’s sub-flap mattress suture improved the IOP lowering effect of DS significantly from 43% in group B to 53% in group A at 6-month ( p  = 0.027). IOP in group A was at 1 week, 1 month and 6-month visits (7.9 ± 1.3, 11.7 ± 2.2 and 13.3 ± 1.9 mmHg respectively) compared to group B (10.1 ± 4.6, 14.1 ± 5.2 and 16.8 ± 4.1 mmHg respectively) ( p  = 0.025, 0.041 and 0.001 respectively). UBM parameters were significantly larger in group A at 1 and 6 months. Strong statistically significant negative correlations were established between IOP and all the UBM parameters apart from intrascleral lake height at the first and sixth month ( p  < 0.01 in all of them). Finally, significant correlations were found between IOP at 6 months and whole bleb anteroposterior length and height at 1 month ( p  = 0.001). Conclusion Adding Ahmed’s sub-flap mattress suture to routine DS is an effective economical addition that will enhance the IOP lowering effect of DS. Also, assessment of the bleb by UBM is useful in predicting the success of deep sclerectomy surgery. Key messages What is known: Ahmed’s sub-flap mattress suture proved to be an effective economical addition to deep sclerectomy. What is new : UMB parameters are significantly larger in Ahmed’s sub-flap mattress suture deep sclerectomy than in conventional deep sclerectomy. UBM parameters in early postoperative period in deep sclerectomy can be used as indication for late success or failure.

Background/aimsThe association between the development of cystoid macular oedema (CMO) following uneventful cataract surgery and prostaglandin analogue (PGA) therapy has not been fully determined. The study aim was to investigate whether discontinuation of PGA therapy following uneventful cataract surgery affected the incidence of postoperative CMO.MethodsA prospective randomised controlled trial of 62 eyes of 62 participants with ocular hypertension (OH) or primary open angle glaucoma (POAG) treated with PGAs prior to cataract surgery. Participants were randomised to continue with PGA therapy after cataract surgery (CPGA) (n=31) or to discontinue PGA therapy (n=31). The primary outcome measure was the development of CMO at 1-month postoperatively, determined by a masked observer assessment of optical coherence tomography scans. The secondary outcome measure was change from baseline intraocular pressure (IOP).ResultsThe incidence of CMO was identical in both groups at 12.9% (4 of 31 eyes) at the 1-month postoperative visit (OR 1.000; 95% CI 0.227 to 4.415). At 1-month postoperatively, the IOP was significantly lower in the CPGA group compared with baseline IOP.ConclusionContinuation of PGA therapy following uneventful cataract surgery in eyes with normal macular morphology did not increase the incidence of CMO. Continuation of PGA therapy significantly reduced IOP at 1-month postoperatively suggesting that, when indicated, it might be beneficial to continue PGA therapy in patients with POAG or OH after uneventful cataract surgery in the absence of other risk factors for developing CMO.

Purpose Cataract and glaucoma, often coexist and present a surgical challenge requiring optimal visual and IOP outcomes. This study compared the clinical outcomes of phaco-trabeculectomy (PHACO-Trab) and manual small incision cataract surgery with trabeculectomy (MSICS-Trab) in patients with coexisting cataract and primary open-angle glaucoma. Methods This prospective, randomized, interventional single-masked clinical trial enrolled 200 eyes from 122 patients with coexisting cataract and primary open-angle glaucoma. Patients were assigned to undergo either phacoemulsification with trabeculectomy (PHACO-Trab) or manual small incision cataract surgery with trabeculectomy (MSICS-Trab). At 24 weeks, 151 eyes from 92 patients completed follow-up and were analyzed (PHACO-Trab, n  = 77; MSICS-Trab, n  = 74). The primary outcome was change in intraocular pressure (IOP), while secondary outcomes included best-corrected visual acuity (BCVA), postoperative complications, and reduction in antiglaucoma medications, assessed up to 24 weeks. Data was analyzed using SPSS v22; independent t-tests and chi-square tests compared continuous and categorical variables, respectively, while multivariate logistic regression identified predictors of surgical failure. Statistical significance was defined as p  < 0.05. Results Both PHACO-Trab and MSICS-Trab significantly improved BCVA and reduced IOP at 24 weeks. Mean BCVA was 0.414 logMAR (PHACO-Trab) vs. 0.523 logMAR (MSICS-Trab) ( p  = 0.187), and mean IOP dropped to 15.31 ± 6.28 mmHg and 14.38 ± 3.24 mmHg, respectively ( p  = 0.204). Complete surgical success was similar: 71.4% (PHACO-Trab) vs. 70.3% (MSICS-Trab) ( p  = 0.939). MSICS-Trab had significantly higher rates of hypotony ( p  = 0.043), posterior capsule opacification ( p  = 0.047), and surgically induced astigmatism ( p  < 0.0001). Refractive outcomes were more favorable in PHACO-Trab, with more eyes achieving target refraction ( p  = 0.021). Both groups showed significant reductions in the proportion of participants on antiglaucoma medications at endpoint. Independent predictors of surgical failure at 24 weeks were baseline IOP ≥ 21 mmHg (AOR 10.54, 95% CI 2.45–45.37; p  = 0.002), worse visual field mean deviation (AOR 5.68, 95% CI 1.93–16.71; p  = 0.002), and the presence of postoperative complications (AOR 2.59, 95% CI 1.11–6.08; p  = 0.028). Conclusions Both phaco-trabeculectomy and MSICS-trabeculectomy improved visual and IOP outcomes in patients with coexisting cataract and glaucoma. PHACO-Trab showed better refractive results and fewer complications, while MSICS-Trab remains a cost-effective alternative. Within the limits of the sample size and 24-week follow-up, outcomes appeared broadly comparable. Surgical choice should consider patient profile, surgeon expertise, and resource availability. Larger multicenter studies with longer follow-up are needed to confirm these findings. Trial registration number NCT06739343. Registration date December 18, 2024 4:27 PM.

Background/aimsTo compare the efficacy and safety of subtenon injection of mitomycin C (MMC) with that of conventional application of MMC-soaked sponges in trabeculectomy.MethodsIn this multicentre randomised clinical trial, 80 consecutive open-angle glaucoma cases were randomised into two groups; group 1 received a subtenon injection of 0.1 mL of 0.01% MMC, while group 2 received 0.02% MMC-soaked sponges. Primary outcome measure was intraocular pressure (IOP), and secondary outcome measures were endothelial cell count (ECC) changes and bleb morphology according to the Indiana Bleb Appearance Grading Scale. Outcome measures were compared at 1, 3 and 6 months postoperatively. Complete and qualified success was defined as IOP within 6–15 mm Hg without and with medications at month 6, respectively.ResultsMean preoperative IOP was 21.8±5.1 in group 1, which reduced to 10.3±3.7 mm Hg at final visit (p<0.001). Corresponding values for group 2 were 21.8±5 and 10.8±3.5 mm Hg respectively (p<0.001). Complete success was 82.5% in both groups, and qualified success was 0 and 2.5% in groups 1 and 2, respectively. (p=0.316) The blebs tended to be more diffuse, less vascularised and shallower in group 1, at month 6 (p=0.45,<0.001 and <0.007 respectively). ECCs did not change significantly at final visit (p=0.813).ConclusionsSubtenon injection of MMC is a safe and effective alternative to the conventional soaked sponge method. This method produces more favourable bleb morphology after trabeculectomy.Trial registration number NCT02385370, Post-results.

Purpose A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication. Methods Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% ( n = 49). IOP was measured at baseline, day 1–2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters. Results Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint ( P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months. Conclusion The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months. Trial Registry ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.