Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study.

PURPOSE: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma. DESIGN: Multicenter randomized controlled trial. PARTICIPANTS: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management. METHODS: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years. MAIN OUTCOME MEASURES: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety. RESULTS: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare. CONCLUSIONS: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Evaluating Refractive Outcomes after Cataract Surgery.

PURPOSE: To compare methods for evaluating refractive outcomes after cataract surgery to detect outliers. DESIGN: Case series database study of the evaluation of diagnostic technology. PARTICIPANTS: Consecutive patients who had uneventful cataract operations over a 5-year period. METHODS: The intended and postoperative refractive outcome and differences between these were analyzed as a spherical equivalent, cylinder, and spherocylinder. The average keratometry and differences between steep and flat keratometric meridians were used to calculate the intended refractive error. MAIN OUTCOME MEASURES: Outliers were defined as patients for whom the difference between the intended and postoperative refractive errors was more than 3 standard deviations (SDs) away from the mean. RESULTS: A total of 9000 patients were included. Twelve patients had missing data and were excluded. The mean intended refractive outcome was -0.12+0.12×2 (95% lower confidence limit [LCL], -1.94+1.06×44; 95% upper confidence limit [UCL], +0.77+1.05×140). The actual postoperative refractive error was -0.30+0.47×6 (95% LCL, -2.36+1.31×36; 95% UCL, +1.00+1.18×148) with a difference from the intended of -0.18+0.35×7 (95% LCL, -1.91+1.22×38; 95% UCL, +0.75+1.09×145). Treating the components of the refractive error independently, outliers were observed in 82 eyes (0.91%) based on the sphere, 46 eyes (0.51%) based on the spherical equivalent, 115 eyes (1.28%) based on treating the cylinder as a scalar, and 76 eyes (0.85%) based on treating the cylinder as a vector. When the differences between the intended and postoperative refractive errors were calculated as a compound spherocylinder, outliers were observed for 233 eyes (2.59%). CONCLUSIONS: Treating the intended refractive outcome as a spherocylinder improves the precision for detecting clinically significant refractive outliers.

ROYAL COLLEGE OF OPHTHALMOLOGISTS' NATIONAL DATABASE STUDY OF VITREORETINAL SURGERY: Report 7, Intersurgeon Variations in Primary Rhegmatogenous Retinal Detachment Failure.

BACKGROUND/PURPOSE: To audit variations in primary rhegmatogenous retinal detachment (RD) anatomical failure rates between surgeons, grades of surgeons, and techniques of RD surgery. METHODS: Clinical data of a total of 5,857 eyes undergoing primary RD surgery, from 2000 to 2013 were retrospectively extracted from 15 centers using the same commercially available electronic medical record system, from three vitreoretinal units using an in-house electronic medical record, and from the British and Eire Association of Vitreoretinal Surgeons online registry. RESULTS: The 5,857 primary RD operations were performed by 117 surgeons: 3,349 (57.2%) by consultants, 520 (8.9%) by independent nonconsultants, and 1,988 (33.9%) by trainees. Surgery comprised pars plana vitrectomy for 4,666 (79.7%) operations, scleral buckle for 815 (13.9%), and pars plana vitrectomy + scleral buckle for 376 (6.4%). The RD reoperation rate at 6 months after primary surgery was 13.9% (725/5,202) and did not differ significantly between consultants and trainees (P = 0.382). For surgeons contributing ≥50 cases, the mean (range) reoperation rates were 13.1% (6.7%-26.8%), 15.1% (11.3%-18.2%), and 15.3% (9.4%-22.1%) for consultants, independent nonconsultants, and trainee surgeons, respectively. The scleral buckle failure rate was not significantly different from pars plana vitrectomy (P = 0.095). Data were not adjusted for case-mix complexity. CONCLUSION: The grades of surgeons and the technique of surgery were not associated with a significant difference in primary unadjusted RD failure rates.

United Kingdom National Ophthalmology Database Study of Cataract Surgery: Report 3: Pseudophakic Retinal Detachment.

PURPOSE: To investigate time to pseudophakic retinal detachment (RD) after cataract surgery with posterior capsule rupture (PCR) to provide an evidence-based guide for postoperative management. DESIGN: Retrospective case series. PARTICIPANTS: A total of 61 907 eyes of 46 824 patients undergoing cataract surgery. METHODS: Subanalysis of the United Kingdom Royal College of Ophthalmologists' National Ophthalmology Database from 13 sites where data on both cataract and vitreoretinal surgery were recorded on the same electronic medical records system. Overall, 61 907 cataract operations were performed between October 2006 and August 2010. Analyses were restricted to cases with at least 3 months of potential postoperative follow-up. RESULTS: Pseudophakic RD surgery was performed on 131 eyes of 129 patients (0.21%; 95% confidence interval [CI], 0.18%-0.25%). Of these, 36 were in eyes that had PCR during cataract surgery (3.27%; 95% CI, 2.37%-4.50%) and 95 were in eyes that did not have PCR (0.16%; 95% CI, 0.13%-0.19%). For eyes that progressed to RD surgery, the median time to pseudophakic RD surgery was 44 days for eyes with PCR, and 6.3 months for eyes without PCR. For all eyes (both with and without PCR), pseudophakic RD occurred earlier in cases performed by a trainee cataract surgeon. CONCLUSIONS: Pseudophakic RD occurs earlier after cataract surgery complicated by PCR. Surgeon grade is a risk factor for pseudophakic RD. Posterior vitreous detachment and RD symptoms should be discussed with patients who undergo cataract surgery and have PCR to facilitate early attendance, and careful dilated postoperative examination for retinal tears is recommended in the first 2 months after surgery.

Sequential Hypothesis Testing to Characterise the Learning Curve and Monitor Surgical Performance in Retinal Detachment Surgery.

PURPOSE: To characterise the learning curve of primary retinal detachment (RD) repair for trainee surgeons and monitor the outcomes of surgery for established surgeons. PROCEDURES: Primary RD operations were analysed sequentially using the cumulative sum (CUSUM) and the sequential probability ratio test (SPRT). RESULTS: 359 analysed cases of primary RD were audited with a recurrent RD (ReRD) rate of 14.7%. The individual rate of ReRD ranged from 9.4 to 17.4% (p = 0.74). SPRT and CUSUM analyses showed that ReRD occurred at random when operated by senior surgeons but a learning curve was discernible for junior surgeons. There was a trend for a higher proportion of ReRD caused by untreated breaks in cases operated by junior surgeons (p = 0.75). CONCLUSION: SPRT and CUSUM are useful methods to monitor surgical outcomes and should be included in audits of sequential operations such as RD. Trainee surgeons experience a quantifiable learning curve.

THE ROYAL COLLEGE OF OPHTHALMOLOGISTS' NATIONAL OPHTHALMOLOGY DATABASE STUDY OF VITREORETINAL SURGERY: Report 4, Epiretinal Membrane.

PURPOSE: To report pragmatic outcomes from a database study of epiretinal membrane surgery. METHODS: Prospective anonymized clinical audit data from electronic medical records were pooled over 10 years into a national database, from 1,131 primary epiretinal membrane operations, by 69 surgeons, in 16 U.K. vitreoretinal units. RESULTS: The median age of 1,131 patients was 71.6 years. A pars plana vitrectomy and epiretinal membrane peel were combined with internal limiting membrane peel in 17.0% of operations, and cataract surgery in 49.9%. Use of general anesthesia declined from 94.1% in 2001 to 28.9% in 2010. One or more intraoperative complication occurred in 9.8% (8.1% excluding cataract surgery complications). The median preoperative logarithm of the minimum angle of resolution (logMAR) visual acuity improved from 0.60 to 0.30 (Snellen 20/80-20/40) after a median follow-up of 7.0 months; 41.7% of eyes improved ≥0.30 logMAR units (approximately 2 Snellen's lines). The percentages of eyes undergoing subsequent surgery were 3.3%, 1.0%, 0.4%, and 0.8% for epiretinal membrane, retinal detachment, macular hole, and other vitreoretinal indications, respectively. Excluding pseudophakic eyes, 51.7%, 73.2%, and 76.2% of eyes underwent cataract surgery within 1 year, 2 year, and 3 years respectively. CONCLUSION: These results may help vitreoretinal surgeons to benchmark their surgical outcomes, and patients to assess the risks and benefits of surgery.

United Kingdom National Ophthalmology Database study of vitreoretinal surgery: report 3, retinal detachment.

PURPOSE: To describe rhegmatogenous retinal detachment (RD) surgery. DESIGN: National Ophthalmology Database study. PARTICIPANTS: A total of 3403 eyes from 3321 patients undergoing primary RD surgery. METHODS: Participating centers prospectively collected clinical data using a single electronic medical record system, with automatic extraction of anonymized data to a national database, from 2002 to 2010. MAIN OUTCOME MEASURES: Description of the primary procedures performed, intraoperative complication rate, and proportion of eyes undergoing subsequent RD or cataract surgery. We undertook an exploratory analysis of change in visual acuity (VA) using the data available. RESULTS: Of 3403 operations, 2693 (79.1%) were pars plana vitrectomy (PPV), 413 (12.1%) were retinopexy with a scleral buckle (SB), and 297 (8.7%) were PPV with an SB (PPV-SB). For PPV and PPV-SB, 18.8% were with hexafluoroethane, 12.1% were with perfluoropropane, 43.1% were with sulfahexafluoride, 1.8% were with air, 17.9% were with silicone oil, and 10.7% were with cataract surgery. Within 1 year of vitrectomy, 52.1% of phakic eyes had undergone cataract surgery. For all RD operations combined (and excluding cataract surgery complications), 5.1% had 1 or more intraoperative complication, 13.0% underwent further RD surgery, and 8.3% had silicone oil in situ at last review. The RD reoperation rate was 13.3%, 12.3%, and 14.5% for PPV, SB, and PPV-SB, respectively. For 961 eyes with a baseline and final VA measurement, the median presenting logarithm of the minimum angle of resolution VA improved from 1.0 to 0.5 (20/200-20/63) after a median follow-up of 0.6 years. CONCLUSIONS: These results may help vitreoretinal surgeons to benchmark their intraoperative complication rate and reoperation rate and to compare their surgical techniques with their peers'. They suggest that the benefits of RD surgery greatly outweigh the risks.

United Kingdom National Ophthalmology Database study of vitreoretinal surgery: report 2, macular hole.

PURPOSE: To study macular hole (MH) surgery in terms of baseline demographics, intraoperative complications, post-vitrectomy cataract, reoperation, and visual outcome. DESIGN: National Ophthalmology Database study. PARTICIPANTS: A total of 1078 eyes from 1045 patients undergoing primary MH surgery. METHODS: Participating centers prospectively collected clinical data using a single electronic medical record (EMR) system, with automatic extraction of anonymized data to a national database, over 8 years. The following data were extracted for eyes undergoing MH surgery: demographics, procedure elements, intraoperative complications, visual acuity (VA), and further surgery. MAIN OUTCOME MEASURES: Description of the primary procedures performed, intraoperative complication rate, change in VA, proportion of eyes undergoing subsequent surgery for persisting MH, cataract, or retinal detachment. RESULTS: The median age was 70.3 years, with a 2.2:1 female preponderance. All operations included a pars plana vitrectomy (PPV)-41.1% with hexafluoroethane (C2F6), 25.6% with perfluoropropane (C3F8), 24.5% with sulfahexafluoride (SF6), 2.2% with air, and 0.4% with silicone oil. A PPV was combined with internal limiting membrane (ILM) peel in 94.1% and cataract surgery in 40.5%. One or more intraoperative complications occurred in 12.4%. The median presenting logarithm of the minimum angle of resolution (logMAR) VA improved from 0.80 to 0.50 after a median follow-up of 0.6 years; 57.8% of eyes improved ≥0.30 logMAR units (∼2 Snellen lines). The choice of gas tamponade did not significantly influence the visual outcome, but eyes undergoing ILM peel were significantly more likely to gain ≥0.30 logMAR units, as were eyes with poor presenting VA. Subsequently, 4.2% of eyes underwent repeat surgery for MH and 2.4% for retinal detachment, and, excluding pseudophakic eyes, 64.6% underwent cataract surgery within 1 year. CONCLUSIONS: This study provides pooled, anonymized data on the demographics, complications, and visual outcome of MH surgery. This may enable vitreoretinal surgeons to benchmark their case-mix and outcomes, and facilitate risk-benefit and cost-benefit analyses.

Surgeon effects on cataract refractive outcomes are minimal compared with patient comorbidity and gender: an analysis of 490 987 cases.

AIM: To investigate effect of patient age, gender, comorbidities and surgeon on refractive outcomes following cataract surgery. METHODS: Study population: patients on UK national ophthalmic cataract database on cataract operations undertaken between 1 April 2010 and 31 August 2018. Variables examined included gender, age, diabetic retinopathy, glaucoma, high myopia, inherited retinal disease, optic nerve disease, uveitis, pseudoexfoliation, vitreous opacities, retinal pathology, cataract type, previous surgery and posterior capsular rupture. A multivariate normal cross-classified model was fitted to the refractive outcome using Markov Chain Monte Carlo (MCMC) methods with diffuse priors to approximate maximum likelihood estimation. A MCMC chain was generated with a burn-in of 5000 iterations and a monitoring chain of 50 000 iterations. RESULTS: 490 987 cataract operations were performed on 351 864 patients by 2567 surgeons. Myopic and astigmatic errors were associated with posterior capsule rupture (-0.38/+0.04×72), glaucoma (-0.10/+0.05×95), previous vitrectomy (-0.049/+0.03×66) and high myopia (-0.07/+0.03×57). Hyperopic and astigmatic errors were associated with diabetic retinopathy (+0.08/+0.03×104), pseudoexfoliation (+0.07/+0.01×158), male gender (+0.12/+0.05×91) and age (-0.01/+0.06×97 per increasing decade). Inherited retinal disease, optic nerve disease, previous trabeculectomy, uveitis, brunescent/white cataract had no significant impact on the error of the refractive outcome. The effect of patient gender and comorbidity was additive. Surgeons only accounted for 4% of the unexplained variance in refractive outcome. CONCLUSION: Patient comorbidities and gender account for small but statistically significant differences in refractive outcome, which are additive. Surgeon effects are very small.

The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: Report 9, Risk factors for posterior capsule opacification.

BACKGROUND/OBJECTIVES: Posterior Capsule Opacification (PCO) is the most common long-term post-operative adverse occurrence after cataract surgery often requiring treatment with YAG laser posterior capsulotomy. This study aimed to identify potential risk factors, known at the time of cataract surgery, that influence the development of PCO. SUBJECT/METHODS: A retrospective study of publicly funded cataract surgery from The Royal College of Ophthalmologists' National Ophthalmology Database. Eligible for analysis were 500,872 cataract operations performed in 41 participating centres. RESULTS: The 500,872 operations were performed on 243,167 (48.5%) left eyes and 257,705 (51.5%) right eyes from 373,579 patients by 2196 surgeons. Post-cataract PCO was recorded for 61,778 (12.3%) eyes and the six month, one, three, five and nine year observed rates of PCO were 2.3%, 4.4%, 19.7%, 34.0% and 46.9% respectively. Different PCO profiles were observed between IOL materials and the identified risk factors that increased the risk of developing PCO included hydrophilic IOL material, axial length >26 mm, the presence of high myopia and implantation of lower IOL powers and previous vitrectomy surgery, along with younger age and female gender. CONCLUSIONS: Many factors influence the development of PCO relating to the patient, the eye, the lens and the surgery. Some factors are modifiable such as IOL material, therefore the opportunity exists to attempt to reduce PCO rates, benefitting patients and the UK NHS.

Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 8, cohort analysis of the relationship between intraoperative complications of cataract surgery and axial length.

OBJECTIVES: To describe the relationships between axial length and intraoperative complications in patients undergoing cataract surgery. DESIGN: Cohort analysis of the Royal College of Ophthalmologists' National Ophthalmology Database (RCOphth NOD). SETTING: 110 National Health Service Trusts in England, Health Boards in Wales, Independent Sector Treatment Centres and Guernsey. PARTICIPANTS: 820 354 patients, aged 18 years or older, undergoing cataract surgery. Eligible operations were those from centres with at least 50 operations with a recorded axial length measurement and age at surgery between 1 April 2010 and 31 August 2019. INTERVENTIONS: Phacoemulsification where the primary intention was cataract surgery alone. OUTCOME MEASURES: Posterior capsule rupture (PCR) and other recorded intraoperative complications. RESULTS: 1 211 520 eligible operations were performed by 3210 surgeons. The baseline axial length was <21 mm (short eyes) for 17 170 (1.4%) eyes, 21-28 mm (medium eyes) for 1 182 513 (97.6%) eyes and >28 mm (long eyes) for 11 837 (1.0%) eyes. The median age at surgery was younger for patients with long eyes than those with short or medium eyes. The rate of any intraoperative complication was higher for short eyes than medium or long with complication rates of 4.5%, 2.9% and 3.3%, respectively (p<0.001). PCR occurred in 1.40% surgeries overall, and in 1.53%, 1.40% and 1.61% of short, medium and long eyes, respectively (p=0.043, not significant at the 1% level). CONCLUSIONS: Overall PCR rates for cataract surgery in RCOphth NOD contributing centres are lower than previously reported and there is little change in PCR rates by axial length. Short eyes were more likely to have an intraoperative complication than medium or long eyes.

Cost-effectiveness of primary surgical versus primary medical management in the treatment of patients presenting with advanced glaucoma.

SYNOPSIS: Advanced glaucoma is associated with sight loss. This within-trial economic evaluation compares medical and surgical management strategies. At 2 years, medication appears more cost-effective though longitudinal outcomes are an important subject in future research. BACKGROUND/AIMS: Open angle glaucoma (OAG) is a progressive optic neuropathy. Approximately 25% of newly diagnosed patients with OAG present with advanced disease in at least one eye. The vision loss associated with OAG can lead to significant impacts on vision, quality of life and health care resources. The Treatment of Advanced Glaucoma Study is a randomised controlled trial comparing the effectiveness of primary surgical and medical management for newly diagnosed advanced patients with OAG. An economic evaluation was carried out to understand the costs and benefits of each strategy. METHODS: A cost utility analysis was carried out from a National Health Service perspective over a 2-year time horizon inclusive of patient costs. The primary outcome was patient health-related quality of life measured by the EQ-5D-5L, Health Utilities Index 3 (HUI3) and Glaucoma Utility Index (GUI). Results were expressed as incremental cost per QALY gained. RESULTS: Trabeculectomy was associated with higher costs and greater effect, the EQ-5D-5L results have an incremental cost per QALY of £45,456. The likelihood of surgery being cost-effective at a £20, 000, £30,000 and £50,000 QALY threshold is 0%, 12% and 56%, respectively. The results for the HUI3, GUI and inclusion of patient costs do not change the conclusions of the study. CONCLUSION: This is the first study to evaluate management strategies for those presenting with advanced glaucoma. At a 2-year time horizon, medication is the more cost-effective approach for managing glaucoma. Future research can focus on the costs and benefits of the treatments over a longer time horizon.

First eye prediction error improves second eye refractive outcome results in 2129 patients after bilateral sequential cataract surgery.

OBJECTIVE: To define theoretical correction factors for second-eye intraocular lens (IOL) power adjustment based on first eye refractive prediction error (PE). DESIGN: Database study. PARTICIPANTS: We included 2129 patients who underwent bilateral sequential phacoemulsification cataract surgery with the same IOL model. METHODS: Retrospectively calculated PEs (Hoffer Q, Holladay 1, SRK/T) were analyzed for association between paired eyes, examining the effect of interocular differences in axial length (AL) and corneal power. A range of correction factors (CF) derived from the first eye PE were applied to the second eye PE using optimized and non-optimized IOL constants (IOLCs). MAIN OUTCOME MEASURES: Second eye mean absolute error (MAE). RESULTS: Prediction errors of paired eyes were correlated. Interocular corneal power differences exceeding 0.60 diopters (D) were associated with a weaker correlation but interocular AL differences did not affect the correlation. When a 50% CF was applied to second eyes of patients with a first eye PE between ±0.50 and ±1.50 D, it improved refractive outcomes from 30%, 56%, and 92% to 42%, 75%, and 96% within ±0.25 D, ±0.50 D and ±1.00 D, respectively, and reduced the MAE from 0.49 to 0.37 D (P<0.0001). For first eye PE below ±0.50 D, a 50% CF reduced the MAE from 0.32 to 0.30 D (P<0.00001). A 50% CF also reduces second eye MAE for eyes with nonoptimized IOLCs. CONCLUSIONS: A 50% CF reduces second eye PE when either first eye optimized PE is within ±1.50 D or when nonoptimized IOLCs are used. The correlation is weaker when interocular corneal power differences are >0.60 D.

Factors affecting visual recovery after successful repair of macula-off retinal detachments: findings from a large prospective UK cohort study.

OBJECTIVE: To identify risk factors affecting visual outcomes in successfully re-attached macula-off rhegmatogenous retinal detachment (RD) surgery. DESIGN: A prospective study, using online databases, of visual outcomes for 2074 macula-off retinal detachments that were successfully re-attached by vitrectomy and internal tamponade. The database included detailed retinal diagrams of each detachment. MAIN OUTCOME MEASURE: The probability of achieving a post-operative visual acuity (VA) of ≤0.30 LogMAR (Snellen 6/12 or better). RESULTS: Male patients accounted for 64.9% of the sample and the median age was 63 years old. The median pre-operative VA was counting fingers (LogMAR 1.98); this improved to 0.41 LogMAR post-operatively. A post-operative VA of ≤0.30 LogMAR was achieved for 1012 (48.8%) eyes and the factors affecting this were the patient age and gender, pre-operative VA, duration of central vision loss, PVR grade, lens status, total RD and the presence of any ocular co-pathology where the model area under the receiver operator curve was 71.6%. CONCLUSIONS: From the identified risk factors that decrease the probability of achieving a post-operative visual acuity of ≤0.30 LogMAR, the most important modifiable risk factor was the duration of central vision loss. Recent macula-off retinal detachments should be repaired within 72 h of the loss of central vision.

Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT.

BACKGROUND: Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes. OBJECTIVES: To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness. DESIGN: This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial. SETTING: Secondary care eye services. PARTICIPANTS: Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma. INTERVENTION: Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C. MAIN OUTCOME MEASURES: The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety. RESULTS: A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43; p = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg; p < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11; p = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%. CONCLUSIONS: Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year. FUTURE WORK: Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56878850. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 72. See the NIHR Journals Library website for further project information.

Glaucoma is an eye condition in which the intraocular pressure is too high, causing damage to the optic nerve and loss of vision. Patients with severe vision loss at diagnosis are the most at risk of blindness in their lifetime. Lowering pressure in the eye is the only way to prevent further vision loss. Two treatments to lower pressure are commonly used: using eye drops or having an operation known as a trabeculectomy. In England, Wales and Northern Ireland, the National Institute for Health and Care Excellence recommends surgery as the first treatment. However, we do not know which treatment is best for preventing vision loss or which is safest, has the best patient experience or provides the best value for money for the NHS. Therefore, surgery is not usually carried out in the first instance and patients start with eye drops instead. This study compared whether starting treatment with eye drops affected the quality of life of patients with advanced glaucoma more or less than starting treatment with trabeculectomy. We also investigated if initial treatment with surgery and initial treatment with eye drops were equally good at controlling pressure and were equally safe, and how much each treatment cost the NHS. Every patient had an equal chance of starting treatment with surgery or eye drops and they participated in the study for 2 years. We found that quality of life was similar regardless of treatment. Those starting with surgery had lower pressure and needed far fewer types of eye drops than those starting with eye drops. Thirty-nine patients in the eye drop arm required surgery to control their glaucoma. Initial treatment with eye drops was cheaper over 2 years' follow-up. Our study suggests that, over a 2-year period, having surgery in the first instance lowers intraocular pressure more than eye drops and is equally as safe as eye drops. Although eye drops are a cheaper treatment option for the NHS, if the effects of surgery on intraocular pressure are lasting, then the increased cost may be justified.

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS).

OBJECTIVE: To 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. DESIGN: Pragmatic multicentre randomised controlled trial. SETTING: 27 secondary care glaucoma departments in the UK. PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary 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. RESULTS: At 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. CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.

The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 4, equity of access to cataract surgery.

OBJECTIVE: To determine whether socioeconomic status influenced the presenting visual acuity prior to first eye cataract surgery in the English National Health Service. Retrospective case series from The Royal College of Ophthalmologists' National Ophthalmology Database Audit. In total 154,223 patients undergoing first eye cataract surgery at 68 centres in England performed between 1st September 2015 and 31st August 2017. MAIN OUTCOME MEASURE: Social deprivation status and pre-operative visual acuity (VA) between centres for patients undergoing first eye cataract surgery in England. RESULTS: The median social deprivation varied between centres and ranged from decile 2 (2nd most deprived decile) to decile 9 (2nd least deprived decile). The pre-operative VA was reported for 143,401 (93.0%) eyes. The median pre-operative VA was 0.50 LogMAR (6/19), and 27.7% eyes had a preoperative VA of 0.30 LogMAR units (6/12) or better. The median pre-operative VA for each centre ranged from 0.30 to 0.60 LogMAR (6/12 to 6/24). The median pre-operative VA was mostly stable across deciles of social deprivation (0.60 LogMAR for decile 1 and 0.50 LogMAR for all other deciles), and some evidence was found linking greater deprivation to worse pre-operative VA and to lower levels of access. CONCLUSIONS: We found no strong evidence of inequality for gaining access to first eye cataract surgery in this National Ophthalmology Database analysis, however there was a possible trend towards fewer people in the more deprived deciles accessing surgery, and that some of these are presenting with quite marked levels of visual impairment.

Intraocular Pressure Reduction After Real-world Cataract Surgery.

PRéCIS:: A large cohort undergoing cataract extraction was retrospectively analyzed to ascertain the degree of real-world intraocular pressure (IOP) reduction in normal eyes and those with glaucoma, and a predictive formula was developed. PURPOSE: The purpose of this study was to define the real-world degree of IOP reduction after cataract extraction to guide its role as an isolated intervention for glaucoma. MATERIALS AND METHODS: A retrospective analysis was carried out of clinical data collected in 8 clinical sites in the United Kingdom from an electronic medical record system between January 2006 and May 2015. A total of 20,508 eyes without known pathology and 2251 eyes from patients with glaucoma undergoing phacoemulsification and intraocular lens insertion were included. Eyes with intraoperative complications, undergoing additional procedures, axial lengths outside 22 to 26.5 mm, preoperative IOP under 6 mm Hg or over 30 mm Hg, and copathology, except for amblyopia or glaucoma, were excluded. The main outcome measure was the change in preoperative IOP compared with the next recorded visit for up to 12 weeks. RESULTS: In eyes without pathology, the mean reduction in IOP was 1.40 mm Hg (±3.74) compared with 1.03 (±5.02), P-value <0.001, in eyes with a diagnosis of glaucoma. A multiple linear regression model identified preoperative IOP, a glaucoma diagnosis, preoperative corrected visual acuity, age, and axial length as determinants of IOP reduction. The model was validated against an independent cohort. CONCLUSIONS: We quantify mean IOP reduction achieved in a real-world setting from cataract surgery alone. In glaucomatous eyes where angle closure is not differentiated, phacoemulsification alone yields only a modest reduction of IOP.

Progression from ocular hypertension to visual field loss in the English hospital eye service.

BACKGROUND: There are more than one million National Health Service visits in England and Wales each year for patients with glaucoma or ocular hypertension (OHT). With the ageing population and an increase in optometric testing, the economic burden of glaucoma-related visits is predicted to increase. We examined the conversion rates of OHT to primary open-angle glaucoma (POAG) in England and assessed factors associated with risk of conversion. METHODS: Electronic medical records of 45 309 patients from five regionally different glaucoma clinics in England were retrospectively examined. Conversion to POAG from OHT was defined by deterioration in visual field (two consecutive tests classified as stage 1 or worse as per the glaucoma staging system 2). Cox proportional hazards models were used to examine factors (age, sex, treatment status and baseline intraocular pressure (IOP)) associated with conversion. RESULTS: The cumulative risk of conversion to POAG was 17.5% (95% CI 15.4% to 19.6%) at 5 years. Older age (HR 1.35 per decade, 95% CI 1.22 to 1.50, p<0.001) was associated with a higher risk of conversion. IOP-lowering therapy (HR 0.45, 95% CI 0.35 to 0.57, p<0.001) was associated with a lower risk of conversion. Predicted 5-year conversion rates for treated and untreated groups were 14.0% and 26.9%, respectively. CONCLUSION: Less than one-fifth of OHT patients managed in glaucoma clinics in the UK converted to POAG over a 5-year period, suggesting many patients may require less intensive follow-up. Our study provides real-world evidence for the efficacy of current management (including IOP-lowering treatment) at reducing risk of conversion.

Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 6. The impact of EyeSi virtual reality training on complications rates of cataract surgery performed by first and second year trainees.

OBJECTIVE: To investigate the impact of EyeSi surgical simulators on posterior capsule rupture (PCR) rates of cataract surgery performed by first and second year trainee surgeons. DESIGN: A Royal College of Ophthalmologists' National Ophthalmology Database audit study of first and second year surgeons' PCR rates over seven consecutive National Health Service (NHS) years. Participating centres were contacted to ascertain the date when their surgeons had access to an EyeSi machine and whether this was on-site or off-site. Operations were classified as before, after or no access to EyeSi. SETTING: The study took place in 29 NHS Ophthalmology Units in a secondary care setting. RESULTS: Two-hundred and sixty five first and second year trainee surgeons performed 17 831 cataract operations. 6919 (38.8%) operations were performed before access to an EyeSi, 8648 (48.5%) after access to an EyeSi and 2264 (12.7%) operations by surgeons with no access to an EyeSi. Overall, there was a 38% reduction in the first and second year surgeon's unadjusted PCR rates from 4.2% in 2009 to 2.6% in 2015 for surgeons with access to an EyeSi, and a 3% reduction from 2.9% to 2.8% for surgeons without access to an EyeSi. The overall first and second year unadjusted PCR rates for before, after and no access to EyeSi were 3.5%, 2.6% and 3.8%, respectively. The decrease in the with-access to an EyeSi group PCR rate was similar for surgeons with access to an EyeSi 'on site' or 'off site'. CONCLUSIONS: First and second year trainee surgeons' unadjusted PCR rates have decreased since 2009 which has significant benefits for patients undergoing cataract surgery. This 38% reduction in complication rates aligns with the introduction of EyeSi simulator training.