Trabeculectomy in the 21st century: a multicenter analysis.

OBJECTIVE: To evaluate the efficacy and safety of current trabeculectomy surgery in the United Kingdom. DESIGN: Cross-sectional, multicenter, retrospective follow-up. PARTICIPANTS: A total of 428 eyes of 395 patients. METHODS: Consecutive trabeculectomy cases with open-angle glaucoma and no previous incisional glaucoma surgery from 9 glaucoma units were evaluated retrospectively. Follow-up was a minimum of 2 years. MAIN OUTCOME MEASURES: Surgical success, intraocular pressure (IOP), visual acuity, complications, and interventions. Success was stratified according to IOP, use of hypotensive medications, bleb needling, and resuturing/revision for hypotony. Reoperation for glaucoma and loss of perception of light were classified as failures. RESULTS: Antifibrotics were used in 400 cases (93%): mitomycin C (MMC) in 271 (63%), 5-fluorouracil (5-FU) in 129 (30%), and no antifibrotic in 28 (7%). At 2 years, IOP (mean ± standard deviation) was 12.4 ± 4 mmHg, and 342 patients (80%) achieved an IOP ≤ 21 mmHg and 20% reduction of preoperative IOP without IOP-lowering medication, whereas 374 patients (87%) achieved an IOP ≤ 21 mmHg and 20% reduction of preoperative IOP overall. An IOP ≤18 mmHg and 20% reduction of preoperative IOP were achieved by 337 trabeculectomies (78%) without IOP-lowering treatment and by 367 trabeculectomies (86%) including hypotensive medication. Postoperative treatments included suture manipulation in 184 patients (43%), resuturing or revision for hypotony in 30 patients (7%), bleb needling in 71 patients (17%), and cataract extraction in 111 of 363 patients (31%). Subconjunctival 5-FU injection was performed postoperatively in 119 patients (28%). Visual loss of >2 Snellen lines occurred in 24 of 428 patients (5.6%). A total of 31 of the 428 patients (7.2%) had late-onset hypotony (IOP <6 mmHg after 6 months). In 3 of these, visual acuity decreased by >2 Snellen lines. Bleb leaks were observed in 59 cases (14%), 56 (95%) of which occurred within 3 months. Two patients developed blebitis. Bleb-related endophthalmitis developed in 1 patient within 1 month postoperatively and in 1 patient at 3 years. There was an endophthalmitis associated with subsequent cataract surgery. CONCLUSIONS: This survey shows that good trabeculectomy outcomes with low rates of surgical complications can be achieved, but intensive proactive postoperative care is required.

ReGAE 9: baseline factors for success following augmented trabeculectomy with mitomycin C in African-Caribbean patients.

BACKGROUND: To identify the baseline factors influencing success following trabeculectomy with mitomycin C in a case series of African-Caribbean patients. DESIGN: A prospective, observational and non-comparative cohort study. PARTICIPANTS: Forty-seven consecutive African-Caribbean patients (47 eyes) with glaucoma. METHODS: Association between trabeculectomy survival and study factors was examined using Fisher's exact test and the Wilcoxon rank sum test at 12, 24 and 36 months following trabeculectomy. Logistic regression was used to establish the combination of factors best predicting survival. MAIN OUTCOME MEASURES: Surgical success was based upon intraocular pressure reduction to ≤21 mmHg, ≤18 mmHg and ≤15 mmHg without glaucoma medication (criterion 1), or intraocular pressure reduction to ≤21 mmHg, ≤18 mmHg and ≤15 mmHg with or without glaucoma medication (criterion 2). RESULTS: Trabeculectomy survival at 36 months was significantly decreased with the use of preoperative acetazolamide, pseudophakic status and higher preoperative intraocular pressure (P < 0.05). In pseudophakic eyes, there was a lower rate of success for criterion 2 when aiming for an intraocular pressure ≤15 mmHg at 2 years post-trabeculectomy, the odds ratio being 12. CONCLUSIONS: Three major independent risk factors were identified that influenced trabeculectomy failure at 3 years in African-Caribbean ethnicity: the preoperative use of acetazolamide, pseudophakic status and higher preoperative intraocular pressure. The presence of these risk factors may guide the clinician to use a more aggressive antiproliferative and postoperative management regime to enhance survival rates in this high-risk population.

One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis.

BACKGROUND/AIMS: To evaluate the efficacy and safety of the PreserFlo MicroShunt glaucoma device in a multicentre cohort study. METHODS: All consecutive patients who received the microshunt with mitomycin-C (MMC) 0.4 mg/mL from May 2019 to September 2020 in three UK tertiary centres. Primary outcome at 1 year was a complete success, with failure defined as intraocular pressure (IOP) >21 mmHg or <20% reduction, IOP≤5 mmHg with any decreased vision on two consecutive visits, reoperation or loss of light perception vision. Secondary outcomes were IOP, best-corrected visual acuity, medications, complications, interventions and reoperations. We also performed subgroup analyses for severe glaucoma and assessed risk factors for failure. RESULTS: 104 eyes had 1-year follow-up. Complete and qualified success at 1 year were achieved in 51.9% (N=54) and 16.4% (N=17), respectively, and failure occurred in 31.7% (N=33). There was a significant reduction in IOP (mmHg) from preoperatively (23.4±0.8, N=104) to 12 months (14.7±0.6, N=104) (p<0.0001). Antiglaucoma medications also decreased from preoperatively (3.4±0.1, N=104) to 12 months (0.7±0.1, N=104) (p<0.0001). Multivariate analyses showed an association between higher mean deviation and failure (HR 1.055, 95% CI 1.0075 to 1.11, p=0.0227). Complications were hypotony (19.2%; N=20), choroidal detachments (10.6%; N=11), hyphaema (5.8%; N=6) and bleb leak (5.8%; N=6). Needling and 5-fluorouracil injections were performed in 12.5% (N=13) and 33.7% (N=35), respectively, and 11.5% (N=12) required revision surgery. CONCLUSION: The PreserFlo MicroShunt with MMC 0.4 mg/mL showed an overall success rate of 68.3% at 1 year, and led to significant IOP and medication reduction with a low rate of adverse effects.

ReGAE 7: long-term outcomes of augmented trabeculectomy with mitomycin C in African Caribbean patients.

BACKGROUND: To evaluate long-term outcomes and complication rates following trabeculectomy with mitomycin C in a case series of African Caribbean patients. DESIGN: A prospective, observational and non-comparative case series. PARTICIPANTS: Forty-seven consecutive African Caribbean patients (47 eyes) with glaucoma. METHODS: All patients underwent augmented trabeculectomy with mitomycin C for uncontrolled intraocular pressure (IOP). Survival analysis was performed with a minimum of 12 months' follow up. MAIN OUTCOME MEASURES: Surgical success was based upon IOP reduction to ≤ 21 mmHg, ≤ 18 mmHg and ≤ 15 mmHg without glaucoma medication (complete); or IOP reduction to ≤ 21 mmHg, ≤ 18 mmHg and ≤ 15 mmHg with or without glaucoma medication (qualified). RESULTS: The mean follow-up period was 48.6 months. At 3 years post-trabeculectomy 92.6% achieved a qualified success and 59.3% a complete success for an IOP ≤ 21 mmHg. At final follow up the mean IOP reduced from 33.7 mmHg to 13.1 mmHg (P < 0.0001). Survival rates were 96%, 90% and 86% at 12, 24 and 36 months, respectively, with a mean survival time of 97.4 months (95% confidence interval, 86.0-108.8) for an IOP ≤ 21 mmHg. Early postoperative hypotony requiring surgical intervention occurred in four (8.5%) patients. There were no cases of blebitis, endophthalmitis, suprachoroidal haemorrhage, malignant glaucoma or hypotony maculopathy. CONCLUSIONS: Good long-term stable IOP can be achieved with low complication rates and high success rates amongst African Caribbean patients following trabeculectomy with mitomycin C. A proactive postoperative management regime is needed to ensure trabeculectomy survival in high-risk populations.

One-year Outcomes Following Internal Ligation Suture Removal in 350 mm2 Baerveldt Tube Implant Surgery.

Aim: Long-term data of the postoperative management following Baerveldt tube surgery (BVT) is currently limited. This study aims to evaluate the outcome and the safety profile of internal ligation suture removal after BVT surgery for refractory glaucoma. Materials and methods: A prospective, consecutive, non-comparative case series of patients previously undergoing BVT 350 mm2 surgery with 0.4 mg/mL mitomycin C (MMC), 3/0 intraluminal suture (Supramid) insertion, and 10/0 nylon external ligation suture(s). For each patient, data was collected over 12 months after internal ligation suture removal. Follow-up assessments looked at intraocular pressure (IOP), complication rate, and postoperative number of glaucoma medications. Definition of success was adopted as per the World Glaucoma Association recommendations. Results: Twenty-four patients were included. On average, Supramid was removed at 22 ± 18.2 weeks following BVT surgery. Preoperatively, the mean IOP was 30.9 ± 12.6 mm Hg and the average antiglaucoma medications were 1.95 ± 1.13. At 12 months, the mean IOP was 15.2 ± 5.3 mm Hg and the mean number of glaucoma medications was 1.3 ± 0.2. Qualified success with IOP ≤ 21 mm Hg and IOP ≤ 15 mm Hg was achieved in 62.5% and 33.3%, respectively. Only two patients developed hypotony following Supramid removal; both resolved spontaneously within 1 month. Conclusion: Our results show a good IOP reduction and safety profile at 1 year from internal ligation suture removal following BVT. A drop in IOP of approximately 50% from the preoperative IOP can be expected. How to cite this article: Stringa F, Chen R, Agrawal P. One-year Outcomes Following Internal Ligation Suture Removal in 350 mm2 Baerveldt Tube Implant Surgery. J Curr Glaucoma Pract 2022;16(1):20-23.

Glaucoma drainage implants.

Glaucoma drainage devices have traditionally been reserved for refractory glaucoma. However, there is an increasing body of evidence to suggest the use of these implants at an earlier stage in the surgical management of glaucoma. We describe the mechanics behind their function as well as the various implants available. The implants vary in size, surface area and composition and hence the surgical implantation of these devices are described in detail. The knowledge of such devices and their potential complications is fundamental for the successful management of patients who undergo aqueous-shunt surgery. Careful patient selection and optimal postoperative management is critical to the successful patient outcomes.

Optic nerve sheath meningioma in a patient with choroidal malignant melanoma: a case report of a complex neurocristopathy.

PURPOSE: To describe the clinical findings in a patient who had developed choroidal melanoma and was incidentally found to have meningioma of the optic nerve in the same side. METHODS: Clinical and histopathological findings of the case are reviewed and presented. RESULTS: The patient had a choroidal melanoma of the left eye for which she had initially declined surgery and 2 years later when she underwent an examination, an optic nerve sheath meningioma was incidentally found histologic examination. Both tumours are derived from neural crest cells. CONCLUSION: Complex neurocristopathy, a disorder resulting from aberrations in the growth and development of neural crest derived structures has been very rarely described in the eye and orbit. To the best of our knowledge there has been only one previous case report of a combination of neurofibroma in the right upper lid, meningioma in the right middle cranial fossa and uveal malignant melanoma in the left eye. (However in this patient the tumours were at 3 different sites.).

Exploring literature-based definitions of hypotony following glaucoma filtration surgery and the impact on clinical outcomes.

PURPOSE: To highlight the variations in published definitions of hypotony and their impact on reported clinical outcomes. To propose a revised definition, focusing on clinically significant hypotony (CH). METHODS: Literature review of hypotony definitions published between January 2010 and December 2015 was carried out. Numerical definitions for hypotony, its onset, duration and associated clinical signs were recorded. Each definition was applied to surgical outcomes data collected prospectively from a cohort of 300 glaucoma patients treated at a single centre. The sensitivity and specificity of each definition in identifying CH [defined as low intraocular pressure (IOP) with signs of maculopathy hypotony and choroidal detachment] were calculated. RESULTS: A total of 128 eligible papers were identified, and 14 different definitions for hypotony were extracted. In 53 (41.4%), hypotony was not defined. In the remaining 75 (58.6%), the numerical definitions varied between 4 and 8 mmHg, and of these, 24 (32%) included the onset and duration of hypotony as part of the definition. Definition-dependent hypotony rates within the cohort varied between 1% and 59.3%. No statistical differences were found between the groups based on corneal thickness or axial length. Clinically significant hypotony (CH) was identified in 37 (12.3%), with large differences in the sensitivity and specificity among published definition. CONCLUSION: Variations in defining postoperative hypotony can have a large impact on the reported success and failure rates among studies. There is a need for a more robust universal definition, focusing on clinically important signs, to allow better comparison between different treatment modalities.

Systematic Literature Review of Clinical and Economic Outcomes of Micro-Invasive Glaucoma Surgery (MIGS) in Primary Open-Angle Glaucoma.

INTRODUCTION: Primary open-angle glaucoma is estimated to affect 3% of the population aged 40-80 years. Trabeculectomy is considered the gold standard in surgical management of glaucoma; however, it is a technically complex procedure that may result in a range of adverse outcomes. Device-augmented, minimally invasive procedures (micro-invasive glaucoma surgeries, MIGS) have been developed aiming for safer and less invasive intraocular pressure (IOP) reduction compared with traditional surgery. METHODS: This paper presents results from a systematic literature review conducted in accordance with National Institute for Health and Care Excellence requirements for the Medical Technology Evaluation Programme via multiple databases from 2005 to 2016. For clinical outcomes, randomized clinical trials (RCTs) comparing MIGS with trabeculectomy or other therapies, observational studies, and other non-RCTs were included. Clinical outcomes reviewed were the change from baseline in mean IOP levels and change in topical glaucoma medication. Safety was assessed by reported harm and adverse events. For economic evidence, trials on cost-effectiveness, cost-utility, cost-benefit, cost-consequences, cost-minimization, cost of illness, and specific procedure costs were included. Risk of bias was assessed for clinical studies using the Cochrane Risk of Bias tool. RESULTS: A total of nine RCTs (seven iStents®, one Hydrus®, and one CyPass®), seven non-RCTs (three iStent®, three CyPass®, and one Hydrus®), and 23 economic studies were analyzed. While various forms of trabeculectomy can achieve postoperative IOP of between 11.0 and 13.0 mmHg, MIGS devices described in this review were typically associated with higher postoperative IOP levels. In addition, MIGS devices may result in increased hypotony rates or bleb needling in subconjunctival placed devices, requiring additional medical resources to manage. There is limited available evidence on the cost-effectiveness of MIGS and therefore it remains unclear whether the cost of using MIGS is outweighed by cost savings through decreased medication and need for further interventions. CONCLUSION: Larger randomized trials and real-world observational studies are needed for MIGS devices to better assess clinical and economic effectiveness. Given the shortage of published data and increasing use of such procedures, living systematic reviews may help to provide ongoing and timely evidence-based direction for clinicians and decision makers. This review highlights the current unmet need for treatments that are easy to implement and reduce long-term IOP levels without increasing postoperative aftercare and cost. FUNDING: Santen GmbH, Germany.

Case-control study of risk factors for acute corneal hydrops in keratoconus.

PURPOSE: To determine risk factors for the development of acute corneal hydrops in keratoconus in the UK in a case-controlled study. METHODS: Between November 2009 and December 2010, we prospectively identified 73 individuals who developed acute corneal hydrops. We then identified 174 controls from nine regions in the UK with keratoconus who had not had hydrops. For cases and controls we recorded demographics and clinical features. Univariate and multivariable logistic regressions were performed to identify risk factors. RESULTS: Univariate analysis suggested strong associations between the odds of hydrops and each of vernal keratoconjunctivitis (OR 4.08, 95% CI 1.45 to 11.49, p=0.008), asthma (OR 2.70, CI 1.34 to 5.47, p=0.006), atopic dermatitis (OR 3.13, CI 1.50 to 6.56, p=0.002), learning difficulties (OR 7.84, CI 2.86 to 21.46, p<0.001), previous hydrops (OR 40.2; CI 6.2 to ∞, p<0.001), black ethnicity (OR 2.98, CI 0.98 to 8.99; p=0.05), visual acuity in the worse eye (OR 8.76 CI 3.86 to 19.88; p<0.001) and minimum keratometry of ≥48 D prior to the hydrops (OR 4.91, CI 1.07 to 22.6, p=0.041). The use of a contact lens correction was also found to be associated with the odds of hydrops (OR 0.08; CI 0.03 to 0.19, p<0.001). Multiple variable regression indicated that having vernal keratoconjunctivitis (adjusted OR (AOR) 15, 95% CI 1.30 to 173.7; p=0.03), asthma (AOR 4.92, CI 1.22 to 19.78; p=0.025), visual acuity in worse eye (AOR 4.11, CI 1.18 to 14.32; p=0.026) and a high keratometry value (AOR 4.44, CI 0.85 to 23.18; p=0.077) were independently associated with the odds of hydrops in subjects with keratoconus. CONCLUSION: Some individuals with keratoconus are at high risk of developing acute corneal hydrops. These patients could be managed more aggressively to reduce their risk of developing this complication of their disease.

Bleb needling with subconjunctival injection of sodium hyaluronate 1.4%: 1-year outcomes.

OBJECTIVES: To assess the safety and efficacy of 5-fluorouracil (5-FU)-augmented bleb needling revision (BNR) with subconjunctival Healon GV (sodium hyaluronate 1.4%) over a 12-month follow-up. DESIGN: Retrospective consecutive case series. PARTICIPANTS: We studied 54 patients who had undergone primary BNR with adjunctive 5-FU and routine subconjunctival Healon GV between 2004 and 2007. METHODS: BNR was performed using multiple puncturing motions through the bleb: a 0.4 mL Healon GV injection between the bleb and conjunctiva; and a 5-FU (10 mg in 0.4 mL) injection into the substance of Healon GV. Success was defined as follows: (1) complete success, indicating intraocular pressure (IOP) reduction ≥ 20% and to ≤ 21 mm Hg but > 5 mm Hg without antiglaucoma medication; or (2) qualified success, indicating IOP reduction ≥ 20% and to ≤ 21 mm Hg but > 5 mm Hg with or without antiglaucoma medication. Patients requiring additional filtration surgery during the 12-month follow-up period were considered failures. RESULTS: Data collection was completed for 53 eyes of 46 patients. The IOP fell from a preoperative mean of 22.7 ± 7.95 mm Hg to 16.3 ± 4.34 mm Hg at 12 months (p < 0.001). The complete success rate was 26.4%; the qualified success rate was 43.4%. Of the eyes studied, 28 (52.8%) achieved IOPs of ≤ 16 mm Hg at 12 months. Complications occurred in 16 eyes (30%), and 3 required surgical intervention. CONCLUSIONS: Subconjunctival Healon GV in 5-FU-augmented bleb needling revision is a relatively safe and effective technique for reducing IOP in the short to medium term, and it involves few significant complications.