To compare the efficacy and safety of 2 nonvalved glaucoma drainage devices (GDDs): Ahmed ClearPath (ACP) vs. Baerveldt glaucoma implant (BGI).
Single-center, retrospective, comparative study.
Consecutive patients who underwent ACP or BGI surgery for glaucoma (250 mm2 or 350 mm2 models), had ≥ 6 months of follow-up, and no prior GDD implantation.
Chart review of ACP or BGI surgery in patients with glaucoma at Wills Eye Hospital (2020–2023).
The primary outcome measure was surgical failure at the end of follow-up, defined as intraocular pressure (IOP) > 21 or < 6 mmHg at 2 consecutive visits, progression to no light perception (NLP) vision, glaucoma reoperation, or implant removal. Secondary outcome measures included the rate of postoperative complications and changes in best corrected visual acuity (BCVA), IOP, and glaucoma medications.
A total of 128 eyes of 113 patients (63 ACP, 65 BGI) with similar baseline characteristics and a mean follow-up duration of 19.6 ± 10.8 (median 20.5) months were included. Surgical failure occurred in 12 eyes (9.4%) with no significant difference between ACP and BGI eyes (9.5% vs. 9.2%, respectively; P = 0.810). Reasons for failure included IOP > 21 mmHg (3/12, 25.0%), glaucoma reoperation (5/12, 41.7%), and tube removal (4/12, 33.3%). No eyes progressed to NLP vision. Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure in both groups (P = 0.871). Both groups achieved significant IOP and medication reduction compared to their baseline. Final IOP, BCVA, and complication rates were similar in both groups, but medication number was significantly lower in the ACP group (P = 0.012). Both the 250 mm2 and 350 mm2 models had similar outcomes, but diplopia was significantly associated with the 350 mm2 model of either implant (P = 0.012). Univariate logistic regression analysis did not identify either tube type or plate size as predictors of surgical failure.
This study compares the recently approved ACP vs. BGI. Both implants had similar surgical failures and complication rates. Final IOP was similar in both groups, but ACP achieved lower medication number. Diplopia was significantly associated with the use of 350 mm2 model of either implant. Neither tube type nor plate size were significant predictors of surgical failure.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To compare glaucoma tube outcomes of wet age-related macular degeneration (AMD) eyes receiving anti-VEGF injections versus dry AMD eyes and no anti-VEGF.
Retrospective clinical cohort study.
Patients with wet AMD and a history of anti-VEGF within a year prior or after stand-alone glaucoma tube surgery and eyes with dry AMD and no history of anti-VEGF with at least 6 months of follow-up. Eyes with neovascular glaucoma or anti-VEGF for reason other than wet AMD were excluded.
A Kaplan–Meier analysis compared survival for wet versus dry AMD eyes. Failure was defined as intraocular pressure (IOP) > 21 mmHg or < 20% IOP reduction from baseline or IOP ≤ 5 mmHg for 2 consecutive postoperative visits starting at month 3, additional glaucoma surgery, or no light perception. Complete success was defined as no failure or medications at final follow-up. Hypertensive phase was defined for valved tubes as IOP > 21 mmHg within 3 months of surgery after a reduction to < 22 mmHg during the first postoperative week. Intraocular pressure, percent reduction in IOP, number of glaucoma medications, and early (< 1 year) and late (> 1 year) complications were compared through 5 years.
Survival analysis, IOP, number of medications.
Baseline IOP, number of medications, or tube type were not significantly different between wet (n = 24) and dry AMD eyes (n = 54). No wet AMD eyes failed versus 10 (18%) dry AMD eyes (P = 0.03). Five-year survival was estimated as 100% for wet AMD and 72% for dry AMD (P = 0.04). Wet AMD eyes had lower IOP (10.6 vs. 12.7 mmHg, P = 0.05), greater IOP reduction (60% vs. 49%, P = 0.04), fewer medications (1.2 vs. 2.1, P = 0.02), and more complete success (50% vs. 15%, P = 0.001) at final follow-up (32 vs. 36 months, P = 0.42). Fewer wet than dry AMD eyes experienced hypertensive phase (0/10 [0%] vs. 4/10 [40%], P = 0.04). There were no significant differences in early or late complications.
Exposure to anti-VEGF may influence postoperative wound healing and capsule formation which may improve glaucoma tube surgical outcomes. Prospective data is needed to consider perioperative administration of anti-VEGF for glaucoma tube surgery.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To report timing of diagnosis and treatment of glaucoma following cataract surgery (GFCS) in a large cohort of infants undergoing cataract surgery at a tertiary care center.
Cross-sectional study.
All consecutive infants that underwent cataract surgery over a 30-year period from January 1991 to December 2021 were included if they had at least 1 year follow-up.
The data collection included age at time of cataract surgery, presence of associated ocular or systemic conditions, age at diagnosis of GFCS, and treatment required to control GFCS. Glaucoma diagnosis required intraocular pressure (IOP) > 21 mmHg on > 2 visits with glaucomatous optic nerve head changes and/or visual field changes, or in young children, other anatomic changes such as corneal enlargement or haze or accelerated axial elongation and myopic shift.
The incidence of GFCS was calculated. Linear regression was performed to assess the effect of age at time of cataract surgery. Analysis of risk factors and treatment modalities was performed using univariate and multivariate analysis.
Three hundred eighty-three eyes (260 patients) were analyzed. Median age at surgery was 52 days and median follow-up, 8 years. Glaucoma following cataract surgery was noted in 27% (104/383 eyes; median age at surgery, 45 days; median follow-up, 13 years.) Young age at surgery (< 3 months) was the greatest risk factor (P = 0.001) but the incidence was similar for infants operated in the first, second, or third month of life (25%, 36%, 40%, respectively, P = 0.4). Microcornea (41%, P < 0.0001), poorly dilating pupils (25%, P = 0.001), persistent fetal vasculature (PFV, 13%; P = 0.8), or anterior segment dysgenesis (3%, P = 0.02) were considered as additional risk factors. Surgical intervention was needed for 73% (24/33) eyes with early-onset GFCS compared with 14% (10/71) eyes with later-later onset GFCS (P < 0.0001). Medical treatment was effective in 86% with later-onset GFCS (P = 0.006).
The incidence of GFCS was 27%, and timing of diagnosis occurred in a bimodal fashion. Early-onset GFCS usually requires surgical intervention; medical treatment is effective for later-onset GFCS. Cataract surgery within the first 3 months of life, microcornea, and poorly dilating pupils were major risk factors.
The authors have no proprietary or commercial interest in any materials discussed in this article.
To measure the remodeling of the lamina cribrosa (LC) years after intraocular pressure (IOP) lowering by suturelysis.
Cohort study.
Glaucoma patients were imaged 20 minutes after laser suturelysis after trabeculectomy surgery and at their follow-up appointment 1 to 4 years later (16 image pairs; 15 persons).
Noninvasive OCT imaging of the eye.
Deformation calculated by correlating OCT scans of the LC immediately after IOP lowering by suturelysis and those acquired years later (defined as remodeling strain).
The LC anterior border moved 60.9 ± 54.6 μm into the eye (P = 0.0007), and the LC exhibited regions of large local stretch in the anterior-posterior direction on long-term, maintained IOP lowering, resulting in a mean anterior-posterior remodeling strain of 14.0% ± 21.3% (P = 0.02). This strain and the LC border movement was 14 times and 124 times larger, respectively, than the direct response to IOP lowering by suturelysis. A larger anterior LC border movement was associated with greater mean anterior-posterior remodeling strain (P = 0.004). A thinner retinal nerve fiber layer at suturelysis was also associated with greater mean anterior-posterior remodeling strain at follow-up (P = 0.05). Worsening visual field indexes during follow-up were associated with a greater mean circumferential remodeling strain (P = 0.02), due to regions of large local circumferential stretch of the LC. Eyes with a more compliant LC torsional shear strain response at lysis were associated with worse mean deviation at follow-up (P = 0.03).
Strains and LC border position changes measured years after IOP lowering are far larger than the immediate response to IOP lowering and indicate dramatic remodeling of the LC anatomical structure caused by IOP lowering and glaucoma progression. The remodeling strains indicate substantial local stretch in the anterior-posterior direction and are associated with movement of the LC anterior border into the eye. Eyes with greater direct strain response to IOP lowering, greater glaucoma damage at suturelysis, and greater worsening of visual field at follow-up experienced greater remodeling.
ClinicalTrials.gov Identifier: NCT03267849.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Develop and evaluate the performance of a deep learning model (DLM) that forecasts eyes with low future visual field (VF) variability, and study the impact of using this DLM on sample size requirements for neuroprotective trials.
Retrospective cohort and simulation study.
We included 1 eye per patient with baseline reliable VFs, OCT, clinical measures (demographics, intraocular pressure, and visual acuity), and 5 subsequent reliable VFs to forecast VF variability using DLMs and perform sample size estimates. We estimated sample size for 3 groups of eyes: all eyes (AE), low variability eyes (LVE: the subset of AE with a standard deviation of mean deviation [MD] slope residuals in the bottom 25th percentile), and DLM-predicted low variability eyes (DLPE: the subset of AE predicted to be low variability by the DLM). Deep learning models using only baseline VF/OCT/clinical data as input (DLM1), or also using a second VF (DLM2) were constructed to predict low VF variability (DLPE1 and DLPE2, respectively). Data were split 60/10/30 into train/val/test. Clinical trial simulations were performed only on the test set. We estimated the sample size necessary to detect treatment effects of 20% to 50% in MD slope with 80% power. Power was defined as the percentage of simulated clinical trials where the MD slope was significantly worse from the control. Clinical trials were simulated with visits every 3 months with a total of 10 visits.
A total of 2817 eyes were included in the analysis. Deep learning models 1 and 2 achieved an area under the receiver operating characteristic curve of 0.73 (95% confidence interval [CI]: 0.68, 0.76) and 0.82 (95% CI: 0.78, 0.85) in forecasting low VF variability. When compared with including AE, using DLPE1 and DLPE2 reduced sample size to achieve 80% power by 30% and 38% for 30% treatment effect, and 31% and 38% for 50% treatment effect.
Deep learning models can forecast eyes with low VF variability using data from a single baseline clinical visit. This can reduce sample size requirements, and potentially reduce the burden of future glaucoma clinical trials.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To compare the magnitude and location of automated segmentation errors of the Bruch’s membrane opening-minimum rim width (BMO-MRW) and retinal nerve fiber layer thickness (RNFLT).
Cross-sectional study.
We included 162 glaucoma suspect or open-angle glaucoma eyes from 162 participants.
We used spectral-domain optic coherence tomography (Spectralis 870 nm, Heidelberg Engineering) to image the optic nerve with 24 radial optic nerve head B-scans and a 12-degree peripapillary circle scan, and exported the native “automated segmentation only” results for BMO-MRW and RNFLT. We also exported the results after “manual refinement” of the measurements.
We calculated the absolute and proportional error globally and within the 12 30-degree sectors of the optic disc. We determined whether the glaucoma classifications were different between BMO-MRW and RNFLT as a result of manual and automatic segmentation.
The absolute error mean was larger for BMO-MRW than for RNFLT (10.8 μm vs. 3.58 μm, P < 0.001). However, the proportional errors were similar (4.3% vs. 4.4%, P = 0.47). In a multivariable regression model, errors in BMO-MRW were not significantly associated with age, location, magnitude, or severity of glaucoma loss (all P ≥ 0.05). However, larger RNFLT errors were associated with the superior and inferior sector location, thicker nerve fiber layer, and worse visual field (all P < 0.05). Errors in BMO-MRW and RNFLT were not likely to occur in the same sector location (R2 = 0.001; P = 0.15). With manual refinement, the glaucoma classification changed in 7.8% and 6.2% of eyes with BMO-MRW and RNFLT, respectively.
Both BMO-MRW and RNFLT measurements included segmentation errors, which did not seem to have a common location, and may result in differences in glaucoma classification.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To report the contributing factors to the successful long-term treatment outcomes of a large series of patients with malignant glaucoma (MG).
Retrospective, interventional, consecutive case series.
This study used data collected from 1997 to 2022 from the Glaucoma Division of the Stein Eye Institute, University of California, Los Angeles (UCLA). All patients with MG who underwent treatment at UCLA were enrolled.
The following demographic and clinical data were collected and analyzed for their relevance to successful treatment: age, gender, ethnicity, glaucoma family history, visual acuity (VA), intraocular pressure (IOP), lens status, prior glaucoma diagnosis, prior ocular surgery, prior use of antiglaucoma agents, ultrasonic axial length, qualitative anterior chamber (AC) depth, and treatment methods and outcomes.
Anatomical success was defined as restoration of normal AC depth, indicating relief of the MG episode. Complete success was defined as anatomical success and the reduction of IOP to < 21 mmHg without further surgery, with or without medications.
A total of 74 eyes of 73 patients were identified with a diagnosis of MG. The median (interquartile range) age of the patients at the time of MG presentation was 70 years (19.5) and 49 (75.4%) patients were female. The most common prior diagnosis before MG was primary angle closure glaucoma (PACG) (34 eyes, 51.5%). The initiating event for 30 eyes (45.5%) was glaucoma surgery and for 21 eyes (31.8%) was cataract surgery. Most eyes were pseudophakic (57, 86.4%). Fifty-six eyes underwent medical treatment; MG resolved in 2 eyes with medical treatment alone. Nine eyes (7 eyes = treatment naïve; 2 eyes = failed medical treatment) underwent laser treatment and MG resolved in 5 eyes. Among the 55 eyes which had surgical treatment, 52 eyes failed medical treatment and 3 eyes were treatment naïve. The anatomical success rate with surgical treatment was 96.4% and the most commonly performed surgical procedure was combined pars plana antero-central vitrectomy, hyaloido-zonulectomy, and iridectomy.
Female gender, PACG, and glaucoma surgery were predisposing factors for the development of MG. Medical treatment alone for MG was inadequate in the vast majority of cases. A surgical technique consisting of combined pars plana antero-central vitrectomy, hyaloido-zonulectomy and iridectomy consistently produced high long-term success.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Selective laser trabeculoplasty (SLT) is a first-line treatment for glaucoma and ocular hypertension. However, due to insufficient comparative evidence in efficacy and safety, several SLT treatment protocols are currently used in practice. The objective of this trial was to compare the clinical outcomes of the 4 most significant SLT variants.
Prospective, multicenter, masked, randomized controlled trial (RCT).
Four hundred patients with glaucoma or ocular hypertension. The cohort consisted of both treatment-naive patients and patients undergoing glaucoma treatment, at different stages of disease.
Selective laser trabeculoplasty was performed with 50 ± 5 laser spots in 180 degrees or with 100 ± 10 spots in 360 degrees. The laser power was titrated to either just below the cavitation bubble level (“standard energy”) or to a level producing cavitation bubbles at 50% to 75% of laser applications (“high energy”). Thus, 4 different treatment protocols were included – 180/standard, 180/high, 360/standard, and 360/high. The study adhered as close as possible to regular clinical management, but within a scientific framework.
Reduction of intraocular pressure (IOP) 1 to 6 months after SLT. The proportion of patients achieving a 20% IOP reduction without any further intervention. Time to glaucoma treatment escalation in a Kaplan–Meier survival analysis.
SLT performed with the 360/high protocol was shown to be superior regarding all primary endpoints. The IOP reduction 1 to 6 months after SLT was 5.4 mmHg in the 360/high group, compared to 3.4, 3.2, and 4.2 mmHg with the 180/standard, 180/high, and 360/standard protocols, respectively (P < 0.001). Furthermore, the success rate after 6 months was significantly higher –58.3%, compared with 30.2%, 29.3%, and 41.7% (P < 0.001). The median time to glaucoma treatment escalation was more than twice as long with 360/high SLT –1323 days, compared to 437 days, 549 days, and 620 days (P < 0.001). Although postoperative discomfort was more frequent with the 360/high protocol, symptoms were generally mild and transient. Adverse events were rare in all groups.
The magnitude and longevity of SLT results increases substantially if SLT is performed according to the 360/high protocol, without compromising safety. Therefore, we recommend that 360/high SLT be considered as standard treatment.
The authors have no proprietary or commercial interest in any materials discussed in this article.
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