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.

Clinical Outcomes and Cost Analysis of PreserFlo versus Trabeculectomy for Glaucoma Management in the United Kingdom.

PURPOSE: Clinical evaluation and cost analysis of mitomycin-C-augmented PreserFlo MicroShunt versus trabeculectomy. DESIGN: Retrospective cohort study across 3 teaching hospitals. PARTICIPANTS: A total of 134 consecutive eyes of 129 patients (70 undergoing MicroShunt, 64 trabeculectomy). METHODS: Primary and secondary glaucoma cases with uncontrolled intraocular pressure (IOP) were included. Neovascular glaucoma and surgery combined with cataract extraction were excluded. The cost analysis used results from the clinical study to estimate operative costs (equipment and staff costs) and postoperative costs (follow-up visits, nonglaucoma medications, and postoperative procedures) per eye for PreserFlo and trabeculectomy. MAIN OUTCOME MEASURES: The primary clinical outcome measure was surgical failure (defined as IOP > 21 mmHg or < 20% reduction from baseline, IOP ≤ 5 mmHg, reoperation, or loss of light perception) or qualified and complete success (with or without medication) at 18 months. Secondary measures were IOP, glaucoma medications, visual acuity, mean deviation, time to cessation of steroid drops, complications, surgical time, follow-up visits, postoperative interventions, and reoperations. The cost analysis evaluated costs of PreserFlo compared with trabeculectomy. RESULTS: Baseline characteristics were similar, except for more non-White patients in the trabeculectomy group (51% Black and Asian vs. 32% MicroShunt, P = 0.02) and more cases with prior ab externo glaucoma surgery in the MicroShunt group (19% vs. 3% in the trabeculectomy group, P = 0.004). Overall, 59% of eyes had primary open-angle glaucoma. Mean follow-up was 19.9 months for both groups. At 18 months, surgical failure was 25% for MicroShunt compared with 35% for trabeculectomy (P = 0.18). Failure in MicroShunt cases was due to inadequate IOP reduction (84%) or reoperation for glaucoma (16%). Failure in trabeculectomy cases was due to inadequate IOP reduction (58%), persistent hypotony (29%), or reoperation for glaucoma (13%). Combined blebitis and endophthalmitis rate was 1.4% for MicroShunt and 3.1% for trabeculectomy. Cost analysis showed a savings of £245 to £566 per eye in the MicroShunt group, driven mostly by reduced postoperative procedures and follow-up visits. This is in contrast to prior randomized controlled trial data reporting the incremental cost of $2058 of PreserFlo over trabeculectomy. CONCLUSIONS: Our experience of introducing PreserFlo MicroShunt surgery showed it was safer than trabeculectomy and is a cost-saving and effective option that offers potential to free up highly limited National Health Service resources. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Long-term outcomes in Primary congenital glaucoma, aniridia and anterior segment dysgenesis.

AIM: To determine the long-term outcomes of a cohort of complex patients with primary congenital glaucoma, aniridia and anterior segment dysgenesis. METHODS: Retrospective consecutive series between 1990-2021 in two UK tertiary centres: Guy's and St Thomas' NHS Foundation Trust and King's College Hospital NHS Foundation Trust. We recorded the number and types of surgical and laser treatments along with preoperative and postoperative data, including intraocular pressures (IOP) and anti-glaucoma medications. RESULTS: A total of 41 eyes of 21 patients were included. Primary diagnoses were primary congenital glaucoma in 16 eyes (39.0%), aniridia in 14 eyes (34.2%), and anterior segment dysgenesis in 8 eyes (19.5%). Sixteen eyes (39.0%) had one or more glaucoma surgery or laser procedures for advanced glaucoma, and the long-term follow-up was 12.8 ± 3.6 years. There was a significant decrease in postoperative IOP (mmHg) at 3 months (16.5 ± 1.6; p = 0.0067), 6 months (18.7 ± 2.1; p = 0.0386), 12 months (18.6 ± 1.7; p = 0.0229), 3 years (14.7 ± 1.2; p = 0.0126), 5 years (15.5 ± 1.8; p = 0.0330) and 10 years (15.4 ± 2.3; p = 0.7780), compared to preoperatively (24.1 ± 2.6). Surgical success (complete and qualified) was 62.5%, 50.0%, 43.8%, 46.2%, 45.5% and 28.6% at 3 months, 6 months, 12 months, 3 years, 5 years and 10 years, respectively. There was no significant change in the number of anti-glaucoma drugs postoperatively (p > 0.05). Four eyes (25.0%) had postoperative complications (hyphaema, hypotony) that resolved after conservative management. CONCLUSIONS: Surgical management of these complex eyes with advanced glaucoma is challenging. Overall, the cohort had good surgical outcomes with a significant decrease in IOP by 36.1% after long-term follow-up.

Evaluation of Automated Multiclass Fluid Segmentation in Optical Coherence Tomography Images Using the Pegasus Fluid Segmentation Algorithms.

Purpose: To evaluate the performance of the Pegasus-OCT (Visulytix Ltd) multiclass automated fluid segmentation algorithms on independent spectral domain optical coherence tomography data sets. Methods: The Pegasus automated fluid segmentation algorithms were applied to three data sets with edematous pathology, comprising 750, 600, and 110 b-scans, respectively. Intraretinal fluid (IRF), sub-retinal fluid (SRF), and pigment epithelial detachment (PED) were automatically segmented by Pegasus-OCT for each b-scan where ground truth from data set owners was available. Detection performance was assessed by calculating sensitivities and specificities, while Dice coefficients were used to assess agreement between the segmentation methods. Results: For two data sets, IRF detection yielded promising sensitivities (0.98 and 0.94, respectively) and specificities (1.00 and 0.98) but less consistent agreement with the ground truth (dice coefficients 0.81 and 0.59); likewise, SRF detection showed high sensitivity (0.86 and 0.98) and specificity (0.83 and 0.89) but less consistent agreement (0.59 and 0.78). PED detection on the first data set showed moderate agreement (0.66) with high sensitivity (0.97) and specificity (0.98). IRF detection in a third data set yielded less favorable agreement (0.46-0.57) and sensitivity (0.59-0.68), attributed to image quality and ground truth grader discordance. Conclusions: The Pegasus automated fluid segmentation algorithms were able to detect IRF, SRF, and PED in SD-OCT b-scans acquired across multiple independent data sets. Dice coefficients and sensitivity and specificity values indicate the potential for application to automated detection and monitoring of retinal diseases such as age-related macular degeneration and diabetic macular edema. Translational Relevance: The potential of Pegasus-OCT for automated fluid quantification and differentiation of IRF, SRF, and PED in OCT images has application to both clinical practice and research.

DISEASE CLASSIFICATION OF MACULAR OPTICAL COHERENCE TOMOGRAPHY SCANS USING DEEP LEARNING SOFTWARE: Validation on Independent, Multicenter Data.

PURPOSE: To evaluate Pegasus optical coherence tomography (OCT), a clinical decision support software for the identification of features of retinal disease from macula OCT scans, across heterogenous populations involving varying patient demographics, device manufacturers, acquisition sites, and operators. METHODS: Five thousand five hundred and eighty-eight normal and anomalous macular OCT volumes (162,721 B-scans), acquired at independent centers in five countries, were processed using the software. Results were evaluated against ground truth provided by the data set owners. RESULTS: Pegasus-OCT performed with areas under the curve of the receiver operating characteristic of at least 98% for all data sets in the detection of general macular anomalies. For scans of sufficient quality, the areas under the curve of the receiver operating characteristic for general age-related macular degeneration and diabetic macular edema detection were found to be at least 99% and 98%, respectively. CONCLUSION: The ability of a clinical decision support system to cater for different populations is key to its adoption. Pegasus-OCT was shown to be able to detect age-related macular degeneration, diabetic macular edema, and general anomalies in OCT volumes acquired across multiple independent sites with high performance. Its use thus offers substantial promise, with the potential to alleviate the burden of growing demand in eye care services caused by retinal disease.

Evaluation of an AI system for the automated detection of glaucoma from stereoscopic optic disc photographs: the European Optic Disc Assessment Study.

OBJECTIVES: To evaluate the performance of a deep learning based Artificial Intelligence (AI) software for detection of glaucoma from stereoscopic optic disc photographs, and to compare this performance to the performance of a large cohort of ophthalmologists and optometrists. METHODS: A retrospective study evaluating the diagnostic performance of an AI software (Pegasus v1.0, Visulytix Ltd., London UK) and comparing it with that of 243 European ophthalmologists and 208 British optometrists, as determined in previous studies, for the detection of glaucomatous optic neuropathy from 94 scanned stereoscopic photographic slides scanned into digital format. RESULTS: Pegasus was able to detect glaucomatous optic neuropathy with an accuracy of 83.4% (95% CI: 77.5-89.2). This is comparable to an average ophthalmologist accuracy of 80.5% (95% CI: 67.2-93.8) and average optometrist accuracy of 80% (95% CI: 67-88) on the same images. In addition, the AI system had an intra-observer agreement (Cohen's Kappa, κ) of 0.74 (95% CI: 0.63-0.85), compared with 0.70 (range: -0.13-1.00; 95% CI: 0.67-0.73) and 0.71 (range: 0.08-1.00) for ophthalmologists and optometrists, respectively. There was no statistically significant difference between the performance of the deep learning system and ophthalmologists or optometrists. CONCLUSION: The AI system obtained a diagnostic performance and repeatability comparable to that of the ophthalmologists and optometrists. We conclude that deep learning based AI systems, such as Pegasus, demonstrate significant promise in the assisted detection of glaucomatous optic neuropathy.

Residual Angle Closure One Year After Laser Peripheral Iridotomy in Primary Angle Closure Suspects.

PURPOSE: To determine the incidence and baseline clinical and anterior segment optical coherence tomography (AS-OCT) predictors associated with residual angle closure as assessed by gonioscopy 1 year after laser peripheral iridotomy (LPI) in primary angle closure suspects (PACS). DESIGN: Subanalysis of randomized controlled trial data. METHODS: AS-OCT images from 181 PACS subjects ≥50 years of age were analyzed using customized software before and 1 year after LPI. Other parameters assessed were intraocular pressure (IOP) and axial length (Axl). Residual angle closure was defined as the inability to see the posterior trabecular meshwork for at least 2 quadrants on gonioscopy after LPI. Multivariate regression analysis determined the baseline predictors of residual angle closure 1 year after LPI. RESULTS: The mean age of participants was 62.4 (standard deviation 9.9) years. The majority were female (137, 75.7%) and Chinese (174, 96.1%). At 1 year post LPI, 148 (81.8%) subjects had gonioscopic residual angle closure. Univariate analysis showed that baseline Axl, anterior chamber area, anterior chamber volume, angle opening distance at 750 µm from the scleral spur, and angle recess area were smaller while baseline lens vault and iris curvature were larger in residual angle closure subjects (all P < .05). Multivariate analysis revealed that baseline iris volume (B = -0.08, P = .035) and baseline IOP (B = 0.23, P = .032) were predictors for residual angle closure. CONCLUSIONS: One year after LPI, >80% of PACS had gonioscopic residual angle closure. Greater baseline iris volume and higher IOP at baseline are independent risk factors for residual gonioscopic angle closure.

Clinical effectiveness of brinzolamide 1%-brimonidine 0.2% fixed combination for primary open-angle glaucoma and ocular hypertension.

The main first-line treatment strategy for glaucoma is to reduce intraocular pressure (IOP) by topical ocular hypotensive medications, but many patients require multiple medications for adequate IOP control. Fixed-combination therapies provide several benefits, including simplified treatment regimens, theoretical improved treatment adherence, elimination of the potential for washout of the first drug by the second, and the reduction in ocular exposure to preservatives. ß-Adrenoceptor antagonists (particularly 0.5% timolol) are the most commonly used agents in combination with other classes of drugs as fixed-combination eyedrops, but they are contraindicated in many patients, owing to local allergy or systemic side effects. A fixed-combination preparation without a ß-blocker is therefore warranted. This paper reviews the clinical effectiveness of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) for use in patients with primary open-angle glaucoma and ocular hypertension. We searched PubMed and the ClinicalTrials.gov registry, and identified three randomized controlled trials comparing BBFC vs its constituents (brimonidine vs brinzolamide), and one comparing BBFC with unfixed brimonidine and brinzolamide. All of the studies demonstrated mean diurnal IOP to be statistically significantly lower in the BBFC group compared with constituent groups and noninferior to that with the concomitant group using two separate bottles. The safety profile of BBFC was consistent with that of its individual components, the most common ocular adverse events being ocular hyperemia, visual disturbances, and ocular allergic reactions. Common systemic adverse effects included altered taste sensation, oral dryness, fatigue, somnolence, and decreased alertness. BBFC seems to be a promising new fixed combination for use in glaucoma patients. However, long-term effects of BBFC on IOP, treatment adherence, and safety need to be determined.

A Genetic Variant in TGFBR3-CDC7 Is Associated with Visual Field Progression in Primary Open-Angle Glaucoma Patients from Singapore.

PURPOSE: To investigate whether known genetic loci for primary open-angle glaucoma (POAG) are associated with visual field (VF) progression in patients from a Singaporean Chinese population. DESIGN: Retrospective study. PARTICIPANTS: Patients with 5 or more reliable VF measurements who were being followed up at a Singapore hospital. METHODS: Visual field progression was identified using Progressor software version 3.7 (Medisoft, Leeds, United Kingdom) and defined by pointwise linear regression (PLR) criteria as follows: any 2 contiguous points in the same hemifield progressing (≤-1.00 dB/year for inner points and ≤-2.00 dB/year for edge points; P < 0.01). Single nucleotide polymorphisms (SNPs) and their proxies from 10 POAG-associated loci (CAV1-CAV2, CDKN2B-AS1, SIX1-SIX6, an intergenic region on chromosome 8q22, ABCA1, GAS7, AFAP1, GMDS, PMM2, and TGFBR3-CDC7) identified from genome-wide association studies were tested for association with VF progression using logistic regression with an additive genetic model adjusting for age, gender, average intraocular pressure (IOP), central corneal thickness (CCT), and baseline vertical cup-to-disc ratio (VCDR). MAIN OUTCOME MEASURE: Visual field progression. RESULTS: Of the 1334 patients included in the study, 469 subjects (35.1%) completed 5 or more reliable VF measurements (mean follow-up, 9.01 years; standard deviation, 5.00 years). The mean age of patients was 59.6 years (standard deviation, 9.0 years); 305 patients were men and all were Chinese. The average IOP in eyes fulfilling PLR progression was 16.5 mmHg versus 17.7 mmHg in those who did not (P = 0.52). Univariate analysis revealed that increased VCDR (P = 0.003), reduced CCT (P = 0.045), and reduced superior and inferior retinal nerve fiber layer thickness (P = 0.01, respectively) were associated with VF progression. No clinical or structural features were associated significantly with VF progression on multivariate analysis. The rs1192415 index SNP in TGFBR3-CDC7 (P = 0.002; odds ratio, 6.71 per risk allele) was the only SNP associated with VF progression. CONCLUSIONS: The presence of the index SNP rs1192415 (TGFBR3-CDC7) was associated with VF progression in POAG patients. These findings warrant further investigation in independent cohorts.

The role of lens extraction in the current management of primary angle-closure glaucoma.

PURPOSE OF REVIEW: Lens extraction for primary angle-closure glaucoma (PACG) is a subject of increased interest recently, with advocates promoting its benefits of anatomical opening of the angle, intraocular pressure (IOP) reduction and improved vision. The present review seeks to evaluate recent available evidence to provide clarity on this potential intervention within the armamentarium of approaches for PACG. RECENT FINDINGS: The emergence of recent case-control studies, cohort studies and randomized controlled trials has provided a stronger evidence base to equip ophthalmic surgeons with the necessary information to utilize lens extraction in the management of PACG, and to consider whether this should be combined with trabeculectomy or goniosynechialysis. Imaging modalities such as anterior segment optical coherence tomography have yielded new insights into the mechanical features of the lens in angle closure, with the lens thickness and lens vault now quantifiable. A trend is emerging regarding the improvement in IOP control, reduced complication rates and reduced need for IOP-lowering medications in patients who undergo lens extraction for PACG. These issues are discussed, along with aspects of preoperative assessment and surgical techniques. SUMMARY: Good outcomes in terms of long-term IOP control have been found following lens extraction for PACG. Lens extraction should be considered in patients with PACG, especially with hyperopia, or a thick and anteriorly vaulted lens.

Bilateral visual loss: more than meets the eye.

A 72-year-old woman presented with acute onset bilateral visual loss. She had no other symptoms or signs, but had a complex past medical history including blood transfusions and immunosuppression. T2-weighted magnetic resonance imaging demonstrated bilateral occipital lobe vasogenic edema, consistent with posterior reversible encephalopathy syndrome (PRES). Her vision improved with conservative management.

Secondary corneal amyloidosis in keratoconus.

We describe the case of a 37-year-old caucasian man with a history of keratoconus and long-term hard contact lens wear. Histological analysis of the corneal button after penetrating keratoplasty revealed staining with Congo red and apple green birefringence detected using polarized light. In the absence of other systemic or ocular pathology, the authors infer this amyloid deposition to be secondary to keratoconus and endeavor to discuss the possible etiopathogenesis of the disease.

A national survey of the management of congenital nasolacrimal duct obstruction in the United kingdom.

PURPOSE: To survey national variation in the management of congenital nasolacrimal duct obstruction, particularly the timing of intervention and the use of nasolacrimal intubation, nasal endoscopy, and assistance from an ear, nose, and throat surgeon at different stages of management. METHODS: A telephone survey was conducted of 100 ophthalmologists in the United Kingdom who were involved in the management of congenital nasolacrimal duct obstruction. A sequential management protocol was established for each, including the nature of procedures, their timing, and the use of nasal endoscopy and ear, nose, and throat surgeons. RESULTS: Of those surveyed, 49% use the dye disappearance test for diagnosis. Eighty-four percent suggest lacrimal sac massage to parents. No surveyed ophthalmologists perform "office" probing or balloon dilation. Seventy-four percent perform initial probing after 1 year, with 25% using nasal endoscopy. If symptoms persist, 64.5% (60 of 93) repeat the probing, whereas 35.5% (33 of 93) intubate the lacrimal system. The use of nasal endoscopy increases to 50.5% (47 of 93). By the third intervention, 77.6% (45 of 58) perform lacrimal intubation, with 72.4% (42 of 58) using nasal endoscopy. All opt for dacryocystorhinostomy as the fourth intervention and 28.3% (13 of 46) perform this procedure themselves, whereas 71.7% (33 of 46) refer the patient to another practitioner. In total, 65% (65 of 100) use tubes at some stage of management, 58% (58 of 100) make some use of nasal endoscopy, and 33% (33 of 100) involve ear, nose, and throat surgeons. CONCLUSION: Based on the results of this survey, huge variation exists in the management of congenital nasolacrimal duct obstruction in the United Kingdom. Most ophthalmologists intervene soon after patients reach 1 year of age. The rate of nasal endoscopy increases with successive interventions, especially to aid with nasal intubation, either alone or with the assistance of ear, nose, and throat surgeons.

Acute suprachoroidal haemorrhage post-tenecteplase thrombolysis for myocardial infarction: management considerations.

We report a case of a 63-year-old man who received intravenous tenecteplase as thrombolytic therapy for an inferior ST elevation myocardial infarction. Three hours later he complained of blurred vision in the right eye and on examination had sustained a suprachoroidal haemorrhage. With conservative treatment the haemorrhage resolved, leading to a normalisation of visual acuity. To the authors' knowledge, no case reports exist of this rare complication following intravenous tenecteplase. We discuss implications for further thrombolysis and anticoagulation.

Successful Surgical Intervention for Childhood Pterygium Using a Conjunctival Autograft.

Childhood pterygia are extremely rare and no consensus currently exists regarding surgical management in cases of significant symptomatology. The authors describe a case of a childhood pterygium in a 9-year-old boy successfully treated with a superior conjunctival autograft. At 6 months of follow-up, no signs of recurrence were detected and the patient reported marked improvement in symptoms. Use of this technique may be beneficial in certain cases of childhood pterygia.