Prevalence of zonulopathy in primary angle closure disease.

BACKGROUND: To determine the prevalence of zonulopathy in a large cohort of eyes with primary angle closure disease (PACD) that underwent cataract surgery. METHODS: Retrospective consecutive case series of PACD eyes (including primary angle closure suspect, primary angle closure, and primary angle closure glaucoma) that underwent phacoemulsification cataract surgery or clear lens extraction between 2009 and 2020 at a single ophthalmology centre. Those with risk factors for zonulopathy such as history of trauma, pseudoexfoliation syndrome, intraocular surgery, retinitis pigmentosa or connective tissue disorders were excluded. The primary outcomes included the prevalence of zonulopathy assessed intraoperatively and secondary pigment dispersion syndrome. RESULTS: In our cohort of 806 consecutive PACD eyes, the prevalence of zonulopathy was 7.3% (59 of 806 eyes) - significantly greater than the 0.46%-2.6% range reported for the general population (p < 0.001). Intraoperative signs of zonular weakness included floppy capsular bag (29 eyes, 3.6%), zonular laxity (25 eyes, 3.1%) and zonular dehiscence (11 eyes, 1.4%). Among these eyes, capsular tension ring was used in 23 eyes (39.0%), six eyes (10.2%) experienced vitreous prolapse intraoperatively and underwent anterior vitrectomy, and two eyes (3.4%) experienced posterior capsular rupture, one of which required a scleral-fixated intraocular lens. Secondary pigment dispersion syndrome was observed in 141 eyes (17.5%). CONCLUSIONS: This study evidenced a high prevalence of zonulopathy among a large cohort of PACD eyes and suggests zonulopathy as a possible under-recognised cause of angle closure. Until more sophisticated imaging modalities become available, awareness about the prevalence of zonulopathy in angle closure disease coupled with careful preoperative examinations can help minimise or prevent the complications of zonulopathy.

A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma: The COMPARE Study.

PURPOSE: To compare the efficacy of different microinvasive glaucoma surgery (MIGS) devices for reducing intraocular pressure (IOP) and medications in open-angle glaucoma (OAG). DESIGN: Prospective, multicenter, randomized clinical trial. PARTICIPANTS: One hundred fifty-two eyes from 152 patients aged 45 to 84 years with OAG, Shaffer angle grade III-IV, best-corrected visual acuity (BCVA) 20/30 or better, and IOP 23 to 39 mmHg after washout of all hypotensive medications. Eyes with secondary glaucoma other than pseudoexfoliative or pigmentary glaucoma, angle closure, previous incisional glaucoma surgery, or any significant ocular pathology other than glaucoma were excluded. INTERVENTION: Study eyes were randomized 1:1 to standalone MIGS consisting of either 1 Hydrus Microstent (Ivantis, Inc, Irvine, CA) or 2 iStent Trabecular Micro Bypass devices (Glaukos Inc, San Clemente, CA). Follow-up was performed 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES: Within-group and between-group differences in IOP and medications at 12 months and complete surgical success defined as freedom from repeat glaucoma surgery, IOP 18 mmHg or less, and no glaucoma medications. Safety measures included the frequency of surgical complications, changes in visual acuity, slit-lamp findings, and adverse events. RESULTS: Study groups were well matched for baseline demographics, glaucoma status, medication use, and baseline IOP. Twelve-month follow-up was completed in 148 of 152 randomized subjects (97.3%). At 12 months, the Hydrus had a greater rate of complete surgical success (P < 0.001) and reduced medication use (difference = -0.6 medications, P = 0.004). More Hydrus subjects were medication free at 12 months (difference = 22.6% P = 0.0057). Secondary glaucoma surgery was performed in 2 eyes in the 2-iStent group (3.9%) and in none of the Hydrus eyes. Two eyes in the Hydrus group and 1 in the 2-iStent group had BCVA loss of ≥2 lines. CONCLUSION: Standalone MIGS in OAG with the Hydrus resulted in a higher surgical success rate and fewer medications compared with the 2-iStent procedure. The 2 MIGS devices have similar safety profiles.

The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes.

PURPOSE: To compare 2 frequently used aqueous shunts for the treatment of glaucoma. DESIGN: International, multicenter, randomized trial. PARTICIPANTS: Patients aged 18 years or older with uncontrolled glaucoma despite maximum tolerated medical therapy, many of whom had failed or were at high risk of failing trabeculectomy. METHODS: Eligible patients were randomized to receive an Ahmed-FP7 valve implant (New World Medical, Inc, Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc, Santa Ana, CA) using a standardized surgical technique. MAIN OUTCOME MEASURES: The primary outcome was failure, defined as intraocular pressure (IOP) outside the target range (5-18 mmHg) or reduced <20% from baseline for 2 consecutive visits after 3 months, severe vision loss, or de novo glaucoma surgery. Secondary outcomes measures included IOP, medication use, visual acuity, complications, and interventions. RESULTS: A total of 238 patients were randomized; 124 received the Ahmed-FP7 implant, and 114 received the Baerveldt-350 implant. Baseline characteristics were similar between groups. Mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. At 5 years, the cumulative failure rate was 53% in the Ahmed group and 40% in the Baerveldt group (P = 0.04). The main reason for failure in both groups was high IOP, and the cumulative de novo glaucoma reoperation rate was 18% in the Ahmed group and 11% in the Baerveldt group (P = 0.22). Hypotony resulted in failure in 5 patients (4%) in the Baerveldt group compared with none in the Ahmed group (P = 0.02). Mean IOP was 16.6±5.9 mmHg in the Ahmed group (47% reduction) and 13.6±5.0 mmHg in the Baerveldt group (57% reduction, P = 0.001). Mean medication use was 1.8±1.5 mmHg in the Ahmed group (44% reduction) and 1.2±1.3 mmHg in the Baerveldt group (61% reduction, P = 0.03). The 2 groups had similar complication rates (Ahmed 63%, Baerveldt 69%) and intervention rates (Ahmed 41%, Baerveldt 41%). Most complications were transient, and most interventions were slit-lamp procedures. CONCLUSIONS: Both implants were effective in reducing IOP and the need for glaucoma medications. The Baerveldt group had a lower failure rate and a lower IOP on fewer medications than the Ahmed group, but had a small risk of hypotony that was not seen in the Ahmed group.

Gonioscopy-Assisted Transluminal Trabeculotomy in Uveitis-Related Ocular Hypertension and Glaucoma.

PRCIS: Gonioscopy-assisted transluminal trabeculotomy (GATT) may be an effective first-line surgery for decreasing intraocular pressure (IOP) and medication burden in patients with uveitis-related ocular hypertension (OHT) or glaucoma. OBJECTIVE: The purpose of the study is to determine the efficacy of GATT in lowering IOP in uveitis-related OHT or glaucoma. METHODS: Retrospective case series that included patients with uveitis-related OHT or glaucoma who underwent GATT with or without concomitant cataract extraction and intraocular lens implantation at 2 Canadian academic centres from July 2018 to May 2022. Primary outcomes were: complete (no medications) and qualified success (with medication), and failure defined as (1) IOP >21 mm Hg with maximal medical therapy, (2) the need for additional glaucoma procedure, (3) loss of light perception secondary to glaucoma, and (4) IOP <6 mm Hg for 3 months. RESULTS: Twenty-one eyes from 18 patients were included with a mean preoperative IOP of 26.2 ± 7.3 mm Hg on 4.3 ± 0.7 classes of glaucoma drops. The average follow-up was 29.2 ± 17.6 months and 76% of eyes (n = 16) had reached at least 12 months of follow-up. At the 12-month follow-up visit, there was a significant decrease in average IOP by 9.9 ± 7.9 mm Hg (38%, P = 0.005) and a decrease of 1.9 in glaucoma medication classes ( P = 0.002). Of eyes, 14% achieved complete success, whereas 80% of eyes achieved qualified success. Six eyes failed (29%) and 5 patients (24%) required additional glaucoma surgery. The most common postoperative complication was hyphema (n = 9; 43%). CONCLUSION: This small case series suggests that GATT may be an effective first-line surgery for decreasing IOP and medication burden in patients with uveitis-related OHT or glaucoma. Further studies with longer follow-ups should be conducted to assess its long-term outcomes.

Preservative-Free Bimatoprost 0.01% Ophthalmic Gel for Glaucoma Therapy: A Phase III Randomized Controlled Trial.

PRCIS: Noninferiority of efficacy was demonstrated for a preservative-free bimatoprost 0.01% compared with BAK-containing bimatoprost 0.01% following a 12-week treatment period in patients with open angle glaucoma or ocular hypertension. Improved tolerability, in particular conjunctival hyperemia, was also observed. PURPOSE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of a preservative-free bimatoprost 0.01% ophthalmic gel (PFB 0.01% gel) compared with preserved bimatoprost 0.01% (PB 0.01%). DESIGN: Phase III, international, multicenter, randomized, 2-parallel group, investigator-masked, 3-month treatment duration. METHODS: Patients with glaucoma or ocular hypertension were randomized after a 7-week run-in/washout period to receive once-daily PFB 0.01% gel (n=236) or PB 0.01% (n=249) for 3 months. The primary efficacy measure was changed from baseline in IOP at week 12. Safety measures included adverse events (AEs) and assessment of conjunctival hyperemia. RESULTS: The mean changes from baseline in IOP at week 12 in the PFB 0.01% gel and PB 0.01% were -9.72±2.97 and -9.47±3.06 mm Hg, respectively, at 8 am , -9.41±3.03 and -9.19±3.12 mm Hg at 10 am , and -8.99±3.36 and -8.54±3.44 mm Hg at 4 pm . Noninferiority of PFB 0.01% gel to PB 0.01% was demonstrated at week 12 based on predetermined criteria (upper 95% CI margin of 1.5 mmHg at all time points). The most frequently reported AE was conjunctival hyperemia; 13 (5.5%) patients with PFB 0.01% gel and 17 (6.8%) patients with PB 0.01%. The percentage of patients experiencing a worsening from baseline in conjunctival hyperemia score was lower with PFB 0.01% gel compared to PB 0.01% at week 6 (20.1% vs. 29.3%, respectively) and week 12 (18.3% vs. 30.4%, respectively). CONCLUSIONS: PFB 0.01% ophthalmic gel has the same efficacy in lowering IOP as PB 0.01% and demonstrated less aggravation of conjunctival hyperemia at weeks 6 and 12.

Three-Year Outcomes of a Schlemm Canal Microstent (Hydrus Microstent) with Concomitant Phacoemulsification in Open-Angle Glaucoma.

PURPOSE: HORIZON trials have reported the medium- and long-term outcomes of the Hydrus microstent. However, outside of randomized clinical trials, outcomes beyond 24 months have not been previously reported. Here, we examine the 3-year outcomes of the Hydrus microstent with cataract surgery outside of a randomized clinical trial setting. DESIGN: Single-surgeon consecutive case series. PARTICIPANTS: Glaucomatous eyes that underwent implantation of a Hydrus microstent with concomitant cataract surgery at a single ophthalmology center in Montreal, Canada. METHODS: Success was defined according to the absence of specific failure criteria: (A) glaucoma reoperation; (B) selective laser trabeculoplasty; (C) intraocular pressure (IOP) < 5 mmHg, > 18 mmHg, or increase in the number of antiglaucoma medications (AGMs) used (after the first postoperative month), or loss of light perception due to glaucoma; (D) aggregation of criteria A-C. Predictors of treatment failure and postoperative changes in IOP and AGM use were assessed. Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell inner plexiform layer (GC-IPL) thickness, visual field mean deviation (VF-MD) and pattern standard deviation (VF-PSD), and adverse events. MAIN OUTCOME MEASURES: Surgical success, predictors of treatment failure, postoperative changes in IOP and AGM use, and structural and functional markers of disease stability. RESULTS: One hundred six eyes were included. The 3-year surgical success according to Criteria A to D was 86%, 83%, 91%, and 67%, respectively. Intraocular pressure decreased by 26.5% from 18.9 ± 4.8 to 13.9 ± 2.3 mmHg (P < 0.001) and AGM use reduced by 33% from 3.0 ± 1.2 to 2.0 ± 1.2 medications (P < 0.001). The postoperative improvement in BCVA was preserved (P < 0.001). The structural and functional markers of disease stability, including CDR, RNFL, and GC-IPL thickness, as well as VF-MD and VF-PSD, remained stable (P > 0.05). Postoperative adverse events were few and transient. CONCLUSIONS: The 36-month results from this study show that the Hydrus microstent with phacoemulsification is safe and effective in reducing the IOP and AGM among patients with mild to severe open-angle glaucoma and can slow down the disease progression by preserving both structural and functional parameters. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Outcomes and risk factors for Kahook Dual Blade excisional goniotomy with concomitant phacoemulsification: a multicentre Canadian study.

OBJECTIVE: To assess the outcomes and failure risk factors for Kahook Dual Blade (KDB) excisional goniotomy with cataract surgery (phaco-KDB) in eyes with various glaucoma subtypes and severities. METHODS: This multisurgeon consecutive case series included glaucomatous eyes with cataract that underwent phaco-KDB and had a minimum follow-up of 12 months postoperatively. Efficacy was assessed by absolute and qualified surgical success (defined by different criteria) and changes in intraocular pressure (IOP) and antiglaucoma medication (AGM) at the last postoperative follow-up. Safety included best-corrected visual acuity, cup-to-disc ratio, visual field mean deviation, retinal nerve fibre layer thickness, and adverse events. RESULTS: A total of 108 eyes of 89 patients with a median follow-up of 18 months (range, 12-47 months) were included. IOP decreased by 26% from 19.1 ± 5.0 mm Hg to 14.1 ± 3.5 mm Hg (p < 0.001), AGM use decreased by 29% from 2.4 ± 1.3 medications to 1.7 ± 1.3 (p < 0.001), and 25% of eyes became free of AGMs (vs 3% at baseline). Qualified success rates achieved for IOP cutoffs of 18, 15, and 12 mm Hg were 87%, 68%, and 46%, respectively. Higher baseline IOP and postoperative incidence of IOP spikes were associated with a higher risk of surgical failure. Best-corrected visual acuity improved postoperatively (p < 0.001), and visual field mean deviation, cup-to-disc ratio, and retinal nerve fibre layer thickness remained stable. Overall, safety was favourable, and adverse events were transient and not sight threatening. CONCLUSION: This multicentre Canadian study provides real-world data that support the safety and efficacy of phaco-KDB in reducing IOP and AGM use with no evidence of disease progression during the follow-up period.

Femtosecond Laser-assisted Cataract Surgery in Patients With Prior Glaucoma Surgery.

PRCIS: Femtosecond laser-assisted cataract surgery (FLACS) is a safe procedure in glaucomatous eyes with prior glaucoma surgery, evidenced by stable intraocular pressure (IOP) and medication use, acceptable success rate, disease stability, and low complication rates at 1-year postoperative. PURPOSE: The purpose of this study was to assess the 1-year efficacy and safety of FLACS in glaucomatous eyes with prior glaucoma surgery. MATERIALS AND METHODS: Retrospective case series of all consecutive glaucomatous eyes with previous glaucoma surgery that underwent FLACS using the Catalys Precision Laser System with or without concomitant glaucoma surgery at a single ophthalmology center, between 2014 and 2020. Efficacy included change in IOP, glaucoma medication use, best-corrected visual acuity, and surgical success at 12 months postoperatively (POM12). Safety included structural and functional measures of disease stability and postoperative adverse events. RESULTS: A total of 57 eyes with an average age of 62.6±8.1 years were included. At POM12, IOP decreased from 14.5±6.6 mmHg to 13.5±3.7 mm Hg (P=0.22) and glaucoma medication use decreased from 2.1±1.5 to 1.8±1.4 with a marginal significance (P=0.089). Best-corrected visual acuity improved significantly in both groups (P<0.001) and surgical success ranged between 74% and 90% according to the study's success criteria. Safety was favorable with disease stability evidenced by lack of deterioration in cup-to-disc ratio, visual field mean deviation, retinal nerve fiber layer thickness, and ganglion cell-inner plexiform layer thickness. One eye with prior history of trabeculectomy experienced transient bleb leak. Other adverse events were minor without sight-threatening sequelae. CONCLUSIONS: The results of this study suggest that FLACS with or without concomitant glaucoma surgery could be a safe procedure in glaucomatous eyes-a population for which FLACS has been relatively contraindicated. Nonetheless, in those with preexisting filtering bleb, extra attention should be paid to the bleb area.

Size Matters: Ab Interno Canaloplasty Revision with Suture Trabeculotomy.

Aim: To report the efficacy of the revision of failed ab interno canaloplasty with micro-invasive suture trabeculotomy (MIST) over a follow-up period of 24 months. Materials and methods: A retrospective analysis was performed on 23 eyes with open-angle glaucoma (OAG), on whom an ab interno canaloplasty revision with MIST was performed for glaucoma progression. The primary outcome was the proportion of eyes with a significant intraocular pressure (IOP) reduction at 12 months post trabeculotomy, defined as an IOP ≤ 18 mm Hg or ≥20% reduction in IOP without any secondary intervention (SI), and with the same or fewer number of glaucoma medications (NGM). All parameters, including best corrected visual acuity (BCVA), IOP, NGM, and SI, were evaluated at 1, 6, 12, 18, and 24 months. Results: At 12 months, eight out of 23 eyes (36.4%) achieved complete success, maintained in six eyes (27.3%) at 24 months. A significantly lower mean IOP was recorded at all visits [14.3 ± 4.0 mm Hg at 24 months vs 23.1 ± 6.8 mm Hg at baseline (BL)] with a percent IOP change of up to 27.3% at 24 months postoperatively. NGM and BCVA did not significantly decrease from BL. A total of 11 eyes (47.8%) needed an SI throughout the follow-up period. Conclusion: Ab interno trabeculotomy in patients with failed canaloplasty was not shown to be effective in providing a satisfactory control of IOP in OAG patients, possibly due to the small suture gauge used in the initial canaloplasty. Clinical significance: Further research is needed to optimize the surgical outcome. How to cite this article: Seif R, Jalbout NDE, Sadaka A, et al. Size Matters: Ab Interno Canaloplasty Revision with Suture Trabeculotomy. J Curr Glaucoma Pract 2022;16(3):152-157.

Short-term efficacy of latanoprostene bunod for the treatment of open-angle glaucoma and ocular hypertension: a systematic literature review and a network meta-analysis.

BACKGROUND/AIMS: To assess the comparative efficacy of latanoprostene bunod (LBN), a novel prostaglandin analogue (PGA), to other medications for open-angle glaucoma and ocular hypertension on lowering intraocular pressure (IOP). METHODS: A systematic literature review adapted from the Li et al (Ophthalmology, 2016) study was conducted. Medline, Embase and PubMed were searched for randomised controlled trials published between 1 January 2014 and 19 March 2020. Studies had to report IOP reduction after 3 months for at least two different treatments among placebo, PGAs (bimatoprost 0.01%, bimatoprost 0.03%, latanoprost, LBN, tafluprost, unoprostone) or apraclonidine, betaxolol, brimonidine, brinzolamide, carteolol, dorzolamide, levobunolol, timolol, travoprost. A Bayesian network meta-analysis was performed to provide the relative effect in terms of mean difference (95% credible interval) of IOP reduction and ranking probabilities. Surface under the cumulative ranking curve (SUCRA) was generated. RESULTS: A total of 106 trials were included with data for 18 523 participants. LBN was significantly more effective than unoprostone (-3.45 (-4.77 to -2.12)). Although relative effect was not significative, compared with other PGAs, LBN numerically outperformed latanoprost (-0.70 (-1.83 to 0.43)) and tafluoprost (-0.41 (-1.87 to 1.07)), was similar to bimatoprost 0.01% (-0.02(-1.59 to 1.55)) and was slightly disadvantaged by bimatoprost 0.03% (-0.17 (-1.42 to 1.07)). LBN was significantly more efficient than the beta-blockers apraclonidine, betaxolol, brimonidine, brinzolamide, carteolol, dorzolamide and timolol. According to SUCRA, LBN was ranked second after bimatoprost 0.03%, followed by bimatoprost 0.01%. CONCLUSION: LBN was significantly more effective than the PGA unoprostone and most of the beta-blockers. Compared with the most widely used PGAs, LBN numerically outperformed latanoprost and travoprost and was similar to bimatoprost 0.01%.

Surgeon Experience as a Risk Factor for Short-Term Failure for Ab Interno Gelatin Microstent: A Canadian Multicenter Propensity-Matched Study.

PURPOSE: To compare the efficacy and safety of early versus later ab interno gelatin microstent placement with mitomycin C. DESIGN: Canada-wide, multicenter, retrospective propensity score-matched cohort study. PARTICIPANTS: Two hundred seventy eyes (135 early cases and 135 later cases) with no prior incisional surgery. METHODS: Surgeons' first 20 patients (early cases group), from 6 glaucoma surgeons across 4 Canadian sites, were matched 1:1 to patients with the closest propensity score from the later (21+) patients (later cases group). MAIN OUTCOME MEASURES: Primary outcome was hazard ratio (HR) of failure of the early versus later cases groups, with failure defined as IOP of less than 6 mmHg with more than 2 lines of vision loss or more than 17 mmHg with no medications (complete success) on 2 consecutive visits despite in-clinic maneuvers (including needling) more than 1 month after surgery. Secondary outcomes were HRs for failure, defined as IOP outside the range of 6 to 14 mmHg and 6 to 21 mmHg with and without allowing for medications (qualified success), interventions, complications, and reoperations. RESULTS: Hazard ratio of failure for early versus later cases groups was 1.38 (95% confidence interval [CI], 0.97-1.96) for the IOP range of 6 to 17 mmHg, 1.29 (95% CI, 0.90-1.84) for 6 to 14 mmHg, and 1.48 (95% CI, 1.03-2.13) for 6 to 21 mmHg without medication and 0.95 (95% CI, 0.55-1.64), 0.95 (95% CI, 0.61-1.48), and 0.95 (95% CI, 0.52-1.75) for the same IOP ranges allowing for medications. Needling rates were 43.0% (early cases group) and 41.5% (later cases group). Complication rates after 1 month occurred in 9.6% (early cases group) and 11.1% (later cases group; P = 0.69). Reoperation rates were 14.8% (early cases group) and 8.1% (later cases group; P = 0.08). CONCLUSIONS: There is some evidence for improved success in the later cases group. Similar needling rates, similar complication rates, and a slightly higher reoperation rate were found for the early cases group. The results suggest that this procedure can be adopted by existing surgeons with current training regimens, although they may see an improvement in their success outcomes over time.

The Ahmed Versus Baerveldt study: one-year treatment outcomes.

OBJECTIVE: To report the 1-year treatment outcomes of the Ahmed Versus Baerveldt (AVB) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: A total of 238 patients were enrolled in the study, including 124 in the Ahmed group and 114 in the Baerveldt group. METHODS: Patients aged 18 years or older with uncontrolled glaucoma refractory to medicinal, laser, and surgical therapy were randomized to undergo implantation of an Ahmed-FP7 valve (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA), to be followed for 5 years. MAIN OUTCOME MEASURES: The primary outcome measure was failure, defined as intraocular pressure (IOP) out of target range (5-18 mmHg with ≥ 20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, additional glaucoma procedures, or loss of light perception. Secondary outcome measures included IOP, medication use, visual acuity, complications, and interventions. RESULTS: There were no significant differences in baseline ocular or demographic characteristics between the study groups with the exception of sex. Preoperatively, the study group had a mean IOP of 31.4 ± 10.8 mmHg on a mean of 3.1 ± 1.0 glaucoma medications with a median Snellen acuity of 20/100. The cumulative probability of failure a 1-year was 43% in the Ahmed group and 28% in the Baerveldt group (P = 0.02). The mean IOP at 1 year was 16.5 ± 5.3 mmHg in the Ahmed group and 13.6 ± 4.8 mmHg in the Baerveldt group (P < 0.001). The mean number of glaucoma medications required was 1.6 ± 1.3 in the Ahmed group and 1.2 ± 1.3 in the Baerveldt group (P = 0.03). Visual acuity was similar in both groups at all visits in the first year (P = 0.66). In the first year after surgery, there were a similar number of patients who experienced postoperative complications in the 2 groups (45% Ahmed, 54% Baerveldt, P = 0.19), but a greater number of patients in the Baerveldt group required interventions (26% Ahmed vs. 42% Baerveldt, P = 0.009). CONCLUSIONS: The Baerveldt-350 group had a higher success rate than the Ahmed-FP7 group after 1 year of follow-up, but required a greater number of interventions. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Long-term outcomes of two first-generation trabecular micro-bypass stents (iStent) with phacoemulsification in primary open-angle glaucoma: eight-year results.

BACKGROUND: The short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up. METHODS: This longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events. RESULTS: A total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease. CONCLUSIONS: Implantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

Matched Cohort Study of Cataract Surgery With and Without Trabecular Microbypass Stent Implantation in Primary Angle-Closure Glaucoma.

PURPOSE: To compare 1-year outcomes of phacoemulsification alone (phaco-only) vs phacoemulsification with implantation of 2 trabecular microbypass stents (iStent or iStent inject; phaco-stent) in eyes with primary angle-closure glaucoma (PACG). DESIGN: Retrospective matched clinical cohort study. METHODS: PACG eyes that underwent phaco-only vs phaco-stent at a single ophthalmology center. Groups were matched for baseline intraocular pressure (IOP) and medication use with a tolerance of ±2 mm Hg and ±1 medication, respectively. Primary outcomes included postoperative change in the mean IOP and medications. One-year outcomes were assessed using generalized estimating equations corrected for baseline intergroup differences. RESULTS: One hundred fifty-eight eyes (79 per group) were included. At 1 year, IOP decreased by 13% (from 16.8 ± 3.1 mm Hg preoperatively) in the phaco-only group (P < .001) and by 27% (from 17.6 ± 3.2 mm Hg) in the phaco-stent group (P < .001). Medication use decreased by 11% (from 1.8 ± 1.3 medications preoperatively) in the phaco-only group (P < .001) and by 46% (from 2.2 ± 1.2 medications) in the phaco-stent group (P < .001). The phaco-stent group experienced significantly larger reductions in IOP and medications compared with the phaco-only group (P < .001). The incidence of IOP spikes was significantly greater in the phaco-only group (18%) compared with the phaco-stent group (4%; P = .005). Safety was favorable with few transient postoperative adverse events. CONCLUSION: The results of this study highlight that phacoemulsification with implantation of 2 trabecular microbypass stents is more effective and possibly more protective than phaco-only in PACG eyes, as evidenced by significantly larger IOP and medication reductions and smaller incidences of IOP spikes among the phaco-stent eyes.

Three-Year Outcomes of Second-generation Trabecular Micro-bypass Stents (iStent inject) With Phacoemulsification in Various Glaucoma Subtypes and Severities.

PRECIS: This longitudinal case series provides valuable long-term data on the safety and efficacy of iStent inject with concomitant cataract surgery. Patients experienced significant and durable reductions in both intraocular pressure (IOP) and medication burden through 3 years postoperative. PURPOSE: The purpose of this study was to examine the 3-year effectiveness and safety of iStent inject second-generation trabecular micro-bypass stent implantation with concomitant phacoemulsification cataract surgery in eyes with various glaucoma subtypes and severities. METHODS: This was a single-center consecutive case series. Three-year outcomes included mean IOP and medications, the proportions of eyes with IOP ≤18, ≤15, and ≤12 mm Hg, and success (absence of secondary glaucoma interventions). Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio, visual field (VF) mean deviation, retinal nerve fiber layer (RNFL), and ganglion cell-inner plexiform layer (GCIPL) thickness, and adverse events. RESULTS: A total of 124 eyes with different glaucoma subtypes and severities were included. At 3 years postoperative, mean IOP reduced from 16.90±3.85 mm Hg preoperatively to 13.17±2.83 mm Hg (22% reduction, P<0.001) and mean medication burden decreased from 2.38±1.29 medications preoperatively to 1.16±1.22 medications (51% reduction, P<0.001). At 3 years, 96% of eyes achieved IOP ≤18 mm Hg (vs. 69% preoperatively), 80% of eyes achieved IOP ≤15 mm Hg (vs. 40% preoperatively), and 42% of eyes achieved IOP ≤12 mm Hg (vs. 7% preoperatively) with 76% of eyes eliminating ≥1 medication and 37% of eyes eliminating ≥2 medications versus preoperative medication burden. The 3-year cumulative survival rate was 74%. Postphacoemulsification BCVA improvement was preserved, and cup-to-disc ratio, VF mean deviation, and RNFL and GCIPL thickness remained stable. A favorable safety profile included no intraoperative complications and few, transient, postoperative adverse events. CONCLUSION: Significant and sustained IOP and medication reductions were achieved through 3 years after iStent inject implantation with cataract surgery in a real-world clinical population with mild-to-severe glaucoma, along with favorable safety including stable BCVA, VF, and RNFL and GCIPL thickness.

Gonioscopy-Assisted Transluminal Trabeculotomy in Younger to Middle-Aged Adults: One-Year Outcomes.

PURPOSE: To assess the 1-year surgical outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in young to middle-aged patients. DESIGN: Retrospective case series. PARTICIPANTS: Eyes of patients between 18 and 64 years of age who underwent GATT, with and without concomitant cataract surgery, at 2 academic centers in Montreal, Canada. METHODS: Success was defined as intraocular pressure (IOP) between 6 and 21 mmHg (criterion A) or between 6 and 18 mmHg (criterion B) and a relative IOP reduction of 20% or more compared with baseline. Failure consisted of not meeting the success criteria at 2 or more consecutive visits after the first postoperative month, reoperation because of uncontrolled IOP or disease progression, or loss of light perception. Predictors of success and postoperative changes in outcome measures, including IOP and medication use, were assessed. Intraoperative and postoperative adverse events were noted. MAIN OUTCOME MEASURES: Success, IOP, and medication reduction at the 1-year follow-up and baseline predictors of surgical success. RESULTS: Fifty-six eyes with a mean age of 46.94 ± 11.81 years and preoperative IOP of 27.70 ± 10.30 mmHg taking 3.73 ± 0.98 glaucoma medications were included. At 1 year, IOP decreased from 27.70 ± 10.30 mmHg before surgery to 14.04 ± 3.75 mmHg (49% reduction; P < 0.001) and medication use decreased from 3.73 ± 0.98 medications before surgery to 1.82 ± 1.47 (51% reduction; P < 0.001). The 12-month success was 84% (according to both criteria), and younger age at diagnosis of glaucoma (18-39 years) was predictive of surgical success. The most common postoperative adverse events included transient hyphema, IOP spikes, and transient microcystic corneal edema. CONCLUSIONS: A paucity of evidence exists regarding the efficacy of GATT in young to middle-aged adults. Our results highlight that this surgical procedure has good 1-year outcomes with an acceptable safety profile, supported by the significant IOP and medication reduction observed after surgery. With younger age at diagnosis of glaucoma being a predictor of surgical success, the pathophysiologic features of open-angle glaucoma in younger patients may be more localized to the trabecular meshwork, therefore making GATT a particularly suitable procedure for these patients.

Preserved Versus Preservative-Free Latanoprost for the Treatment of Glaucoma and Ocular Hypertension: A Post Hoc Pooled Analysis.

INTRODUCTION: To compare the tolerability and efficacy of a preservative-containing latanoprost (PCL) to a preservative-free formulation of latanoprost (PFL) in patients with open-angle glaucoma or ocular hypertension. METHODS: A pooled analysis was performed of data from five published studies. The primary outcome was tolerability as evaluated by the severity of hyperemia. The secondary objectives were patient tolerance based on a composite ocular surface disease (OSD) score arising from ocular signs and symptoms, patient and investigator satisfaction, and a comparison of IOP-lowering efficacy. RESULTS: There were three randomized controlled trials and two observational studies included in the analysis. Conjunctival hyperemia improved significantly in 25.6% (388) of patients switched to the PFL group versus 11.7% (117) of patients switched to the PCL group (p < 0.001). PFL was two times superior to PCL in reducing ocular hyperemia (odds ratio = 1.96; p < 0.001). The mean OSD composite score decreased by 32.2% in patients switched to the PFL group and 14.1% in the PCL group (p < 0.001). At 3 months, the mean IOP was similar between groups (p = 0.312). CONCLUSION: This post hoc pooled analysis confirmed the findings of the individual studies that PFL is as efficacious at reducing IOP as PCL but better tolerated. After switching to PFL, there was twice the improvement in the OSD composite score. PFL was twice as effective at reducing ocular hyperemia and other ocular signs. These findings suggest that PFL has features that may improve patient compliance, thereby potentially improving the IOP-lowering efficacy on a long-term basis.

Preservatives in eye drops for glaucoma can cause side effects such as stinging and eye redness. These side effects can cause some patients to reduce the frequency of the drops as prescribed or stop using the drops. One of the most common drops for glaucoma is latanoprost. This study evaluated whether a preservative-free latanoprost (PFL) is as effective as preservative-containing latanoprost (PCL) for reducing eye pressure and whether PFL is better tolerated in patients with glaucoma. The results of the study indicated that PFL was as effective as PCL for reducing eye pressure. The results also indicated PFL was much better at reducing the side effects related to PCL. For example PFL reduces eye redness up to twofold compared to PCL. By reducing the side effects associated with PCL patients may continue to take their glaucoma drops as directed and thereby reduce the risk of vision loss from glaucoma.

Screening for glaucoma in high-risk populations using optical coherence tomography.

OBJECTIVE: To estimate the diagnostic accuracy of Stratus optical coherence tomography (OCT) for glaucoma screening in high-risk populations. DESIGN: Cross-sectional evaluation of a diagnostic test for screening. PARTICIPANTS: Three hundred thirty-three community-based volunteer participants with risk factors for glaucoma. METHODS: The optic nerve and peripapillary retinal nerve fiber layer (RNFL) of participants' eyes were scanned using the Stratus OCT. Based on an ophthalmologic examination and frequency doubling perimetry, eyes were classified into 4 categories: normal, possible glaucoma, probable glaucoma, and definitive glaucoma. MAIN OUTCOME MEASURES: The sensitivities, specificities, positive and negative likelihood ratios of the RNFL, optic disc parameters, and their combinations were calculated. RESULTS: The right eyes were retained for analyses. After excluding eyes with missing data or with poor quality scans, the data of 210 right eyes were analyzed. Six eyes had definitive glaucoma. Combining the best performing optic nerve head parameters (cup diameter or cup/disc vertical ratio or cup/disc area ratio) and RNFL parameters (superior average or inferior average or overall average) using AND-logic resulted in a sensitivity of 67% (95% confidence interval [CI], 24%-94%), specificity of 96% (95% CI, 92%-98%), a positive likelihood ratio of 17.08 (95% CI, 7.06-41.4), and a negative likelihood ratio of 0.35 (95% CI, 0.11-1.08). CONCLUSIONS: When adequate quality scans may be obtained, the Stratus has moderate sensitivity and high specificity for definitive glaucoma. Specificity is increased when parameters from both the optic nerve head and RNFL scans are combined.

Second-Generation Trabecular Micro-Bypass (iStent inject) with Cataract Surgery in Eyes with Normal-Tension Glaucoma: One-Year Outcomes of a Multi-Centre Study.

PURPOSE: The efficacy and safety of the trabecular micro-bypass stents (iStent and iStent inject) have been well documented in various open-angle glaucoma subtypes. However, their outcomes remain understudied in normal-tension glaucoma (NTG). The present study aimed to assess the 1-year outcomes related to the implantation of two second-generation trabecular micro-bypass stents (iStent inject) concomitant with cataract surgery (CE-TMS), exclusively in eyes with NTG. METHODS: This multi-center, consecutive case series included eyes with cataract and normal-tension glaucoma that underwent CE-TMS to reduce intraocular pressure or glaucoma medication use. The 12-month efficacy measures included change in average intraocular pressure (IOP) and medication burden. Safety included change in best-corrected visual acuity, cup-to-disc ratio, visual field mean-deviation and retinal nerve fiber layer thickness. Intra- or postoperative adverse events were noted. RESULTS: A total of 62 eyes with mild-to-severe NTG and average preoperative IOP of 15.82 ± 2.94 mmHg on 1.50 ± 1.28 glaucoma medications were included. Postoperatively, IOP declined by 22% from 15.82 ± 2.94 mmHg to 12.32 ± 2.58 (p < 0.001), all eyes had IOP ≤ 18 mmHg (versus 74% preoperatively), and half had IOP ≤ 12 mmHg (versus 15% preoperatively). Medication burden decreased by 70% from 1.50 ± 1.28 to 0.45 ± 0.86 (p < 0.001), and 73% of the eyes were medication-free (versus 23% preoperatively). Safety was favorable, with no evidence of sight-threatening adverse events. CONCLUSION: Implantation of iStent inject (two second-generation trabecular micro-bypass stents) combined with cataract surgery is efficacious in reducing IOP and medication burden with a favorable safety profile in eyes with mild-to-severe NTG.

Visual outcomes of combined cataract surgery and minimally invasive glaucoma surgery.

Minimally invasive glaucoma surgery (MIGS) has become a reliable standard of care for the treatment of glaucoma when combined with cataract surgery. This review describes the MIGS procedures currently combined with and without cataract surgery with a focus on visual outcomes based on the literature and the experience of the ASCRS Glaucoma Clinical Committee.