Intraocular Pressure While Using Gonioscopy, SLT, and Laser Iridotomy Lenses: An Ex Vivo Study.

Purpose: The purpose of this study was to measure intraocular pressure (IOP) elevation while applying standard gonioscopy, selective laser trabeculoplasty (SLT), and laser iridotomy procedural lenses. Methods: Twelve cadaver eyes were mounted to a custom apparatus and cannulated with a pressure transducer which measured IOP. The apparatus was mounted to a load cell which measured the force on the eye. Six ophthalmologists performed simulated gonioscopy (Sussman 4 mirror lens), SLT (Latina lens), and laser iridotomy (Abraham lens) while a computer recorded IOP (mm Hg) and force (grams). The main outcome measures were IOP and force applied to the eye globe during ophthalmic diagnostics and procedures. Results: The average IOP's during gonioscopy, SLT, and laser iridotomy were 43.2 ± 16.9 mm Hg, 39.8 ± 9.9 mm Hg, and 42.7 ± 12.6 mm Hg, respectively. The mean force on the eye for the Sussman, Latina, and Abraham lens was 40.3 ± 26.4 grams, 66.7 ± 29.8 grams, and 65.5 ± 35.9 grams, respectively. The average force applied to the eye by the Sussman lens was significantly lower than both the Latina lens (P = 0.0008) and the Abraham lens (P = 0.001). During gonioscopy indentation, IOP elevated on average to 80.5 ± 22.6 mm Hg. During simulated laser iridotomy tamponade, IOP elevated on average to 82.3 ± 27.2 mm Hg. Conclusions: In cadaver eyes, the use of standard ophthalmic procedural lenses elevated IOP by approximately 20 mm Hg above baseline.

Risk communication in cataract surgery.

PURPOSE: Risk communication is an integral aspect of shared decision-making and evidence-based patient choice. There is currently no recommended way of communicating risks and benefits of cataract surgery to patients. This study aims to investigate whether the way this information is presented influences patients' perception of how risky surgery will be. METHODS AND ANALYSIS: Two-arm parallel randomised study and patients referred for cataract surgery were assigned to receive information framed either positively (99% chance of no adverse effects) or negatively (1% chance of adverse effects). Subsequently, patients rated their perceived risk of experiencing surgical side effects on a 1-6 scale. RESULTS: This study included 100 patients, 50 in each study group. Median (IQR) risk perception was 2 (1-2) in the positive framing group and 3 (1-3) in the negative framing group (p<0.0001). Risk framing was the only factor that was significant in risk perception, with no differences found by other patient clinical or demographic characteristics. CONCLUSION: Patients who received positive framing reported lower risk scores for cataract surgery than patients who received negative framing. Patient factors were not identified as significant determinants in patients' perceived risk. Larger longitudinal studies are warranted to further investigate.

Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

Validation of a Wearable Virtual Reality Perimeter for Glaucoma Staging, The NOVA Trial: Novel Virtual Reality Field Assessment.

Purpose: Compare estimated sensitivities of SITA-Standard to the RATA-Standard algorithm of the Radius virtual reality perimeter (VRP), and measure concordance in glaucoma staging. Methods: One hundred adult glaucoma patients-half with suspect or mild glaucoma, and half with moderate or severe-from five clinics performed four 24-2 visual field tests during a single visit, two with the Humphrey Field Analyzer (HFA) and two with Radius, in randomized order: HRHR or RHRH. Only one eye was tested per participant. We used the Wilcoxon rank sum test with Bonferroni correction to compare distributions of estimated sensitivities across all 54 test locations over the 15 to 40 dB measurement range of the Radius. Weighted kappa measured concordance in glaucoma staging between two masked glaucoma experts using Medicare definitions of severity. Results: A total of 62 OD and 38 OS eyes were tested. Estimated sensitivities for SITA-Standard and RATA-Standard were not significantly different for OD, but were for OS-likely because of SITA-Standard OD and OS being significantly different in our sample, but not for RATA-Standard. Low agreement was observed between 15 to 22 dB. Concordance in glaucoma staging was high for both graders: kappa = 0.91 and kappa = 0.93. Average test duration was 298 seconds for RATA-Standard and 341 seconds for SITA-Standard. The correlation in mean deviation was 0.94. Conclusions: Estimated sensitivities of RATA-Standard are comparable to SITA-Standard between 23 to 40 dB with high concordance in glaucoma staging. Translational Relevance: Radius VRP is statistically noninferior to HFA when staging glaucoma using Medicare definitions.

Prophylaxis against intraocular pressure spikes following uncomplicated phacoemulsification: a systematic-review and meta-analysis.

BACKGROUND: To investigate the effect of perioperative intraocular pressure (IOP) lowering medications on controlling postoperative IOP following uncomplicated phacoemulsification. METHODS: Ovid MEDLINE, EMBASE, and Cochrane CENTRAL databases were searched up until November 2022. Randomised controlled trials (RCTs) that assessed IOP change via applanation tonometry in medicated and control arms following uncomplicated cataract surgery in healthy eyes were included. The primary outcome was the weighted mean difference (WMD) of IOP at 2-8 h, 12-24 h, and 1-7 days postoperatively within each medication class or common fixed-combination formulations. Risk of bias was assessed using the revised risk of bias in randomised trials (RoB-2). Level of evidence was rated using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) RESULTS: From 702 screened articles, 30 RCTs involving 2986 eyes were included. There was a statistically significant reduction in IOP favouring treatment arms at 2-8 h (WMD = -3.87 mmHg; 95% CI [-4.75, -3.00]; p < 0.001) and 12-24 h (WMD = -2.69 mmHg; 95% CI [-3.36, -2.02]; p < 0.001), with the effect wearing off beyond 1 day (p = 0.18). Between medication classes, the largest effect at both 2-8 h and 12-24 h was observed with intracameral cholinergics or fixed-combination carbonic anhydrase inhibitor-beta-blocker (FCCB) formulations. Conversely, the smallest effect was observed with prostaglandin analogues, alpha-agonists, and topical carbonic anhydrase inhibitors (CAIs). CONCLUSION: Prophylaxis against acute IOP elevations following uncomplicated cataract surgery is effective. FCCB and intracameral cholinergics are the most effective ocular antihypertensive agents, while alpha-agonists, prostaglandin analogues, and topical CAIs were found to be the least effective. These findings may inform future surgical guidelines.

Association Between Sociodemographic Factors and Self-reported Glaucoma in the National Health Interview Survey: A Population-Based Analysis.

PURPOSE: To investigate the association between social determinants of health (SDH) in the domains of social and community context, education access, environmental context, economic stability, and healthcare access, with glaucoma prevalence. DESIGN: Cross-sectional study. METHODS: The study population consisted of adult participants who answered glaucoma-related questions on the 2017 National Health Interview Survey (NHIS), the most recent iteration that includes glaucoma-related questions. The main outcome measures included the relationships between SDH-related factors and self-reported glaucoma diagnosis as well as self-reported glaucomatous vision loss were examined using univariable and multivariable regression models. RESULTS: In total, 26,696 of 26,742 (99.83%) NHIS respondents were included, of whom 880 (3.30%) reported a glaucoma diagnosis and 275 (1.03%) reported glaucomatous vision loss. Participants were predominantly middle-aged (50.95 ± 18.60 years), female (54.75%), and non-Hispanic White (70.49%). In age-adjusted multivariable regression (n = 25,456), non-Hispanic Black race (odds ratio [OR] = 1.87, 99% CI = [1.37, 2.55], P < .001, compared to non-Hispanic White race) and poor health status (OR = 1.54, 99% CI = [1.00, 2.37], P = .01, compared to good health status) were significant predictors of glaucoma diagnosis. For glaucomatous vision loss, having an income below the poverty threshold (OR = 2.41, 99% CI = [1.12, 5.20], P = .003, compared to income ≥5 times the poverty threshold) was the only significant predictor in univariable analyses. No SDH-related factors were significantly associated with glaucomatous vision loss in multivariable analysis (n = 848). Multicollinearity was minimal (variation inflation factor<1.6 for all independent variables). CONCLUSIONS: Non-Hispanic Black race and poor health status were associated with self-reported glaucoma diagnosis. Physicians and policymakers may consider SDH when assessing clinical risk and designing public health interventions.

Bilaterally subluxed diffractive intraocular lenses: big expectations and even bigger comorbidities.

A 78-year-old woman with an ocular history of cataract surgery with a diffractive intraocular lens (IOL) in each eye has developed fluctuating vision, greater in the right eye than the left eye, after 4 years. She has a history of inactive central serous retinopathy and a vision potential of 20/25 + 2 in the right eye and 20/25 in the left eye. She has well-controlled diabetes, hypertension, and hypercholesterolemia. She has enjoyed her spectacle independence for some time and wishes to have her vision restored. On examination, her uncorrected distance visual acuity (UDVA) was 20/50 in the right eye and 20/25 in the left eye and her uncorrected near visual acuity (UNVA) was J3 in the right eye and J1 in the left eye. Intraocular pressures (IOPs) measured 22 mm Hg in the right eye and 18 mm Hg in the left eye. Pupils had limited reactivity with irregularity in the right eye but no obvious relative afferent pupillary defect. Motility and confrontation visual fields were unremarkable in both eyes. Retinal acuity meter was 20/20 in both eyes, and manifest refraction was plano -1.25 × 105 20/40, J3 in the right eye and +0.50 × 20/25, J1 in the left eye. Pertinent findings on slitlamp examination included temporal iris atrophy and transillumination defects greater in the right eye than the left eye, peripupillary pseudoexfoliative changes in both eyes, significant inferior subluxation of a diffractive 3-piece posterior chamber IOL in the capsular bag with lens-pitting peripherally and few central, moderate pseudophacodonesis, and an open posterior capsule in the right eye. In the left eye, she had mild inferior subluxation of a single-piece acrylic diffractive IOL in the capsular bag with moderate pseudophacodonesis and an open posterior capsule (Figure 1JOURNAL/jcrs/04.03/02158034-202403000-00019/figure1/v/2024-02-20T193212Z/r/image-tiff). All other anterior segment findings were unremarkable. On dilated posterior examination, she had a cup-to-disc ratio of 0.50 in the right eye and 0.65 in the left eye without edema hemorrhage or pallor. There were attenuated vessels in both eyes, posterior vitreous detachment in both eyes, and a few small drusen peripherally in both eyes. There was retinal pigment epithelium irregularity and dropout parafoveal in the right eye and subfoveal in the left eye (Figure 2). There was no evidence of macular edema, subretinal fluid, choroidal thickening, or neovascular membranes. The periphery was unremarkable in both eyes.JOURNAL/jcrs/04.03/02158034-202403000-00019/figure2/v/2024-02-20T193212Z/r/image-tiff What testing would you obtain preoperatively to help guide your decision-making? How would you counsel the patient regarding comorbid conditions and expectations?

Corneal endothelial safety profile in minimally invasive glaucoma surgery.

PURPOSE: To compare 5-year corneal endothelial safety of 3 minimally invasive glaucoma surgery (MIGS) devices (iStent inject , Hydrus Microstent, CyPass Micro-Stent). SETTING: U.S. multicenter trials. DESIGN: Post hoc 5-year analysis from prospective randomized single-masked pivotal trials. METHODS: Mild to moderate open-angle glaucoma subjects received a MIGS implant with phacoemulsification (implant + phaco) or phaco alone (control). In addition, 5-year end points comparing the implant and control groups included proportion of eyes with significant endothelial cell loss (ECL) (>30% or ≥30% vs baseline) and mean endothelial cell density (ECD). RESULTS: Comparable proportions of eyes in the iStent inject + phaco and control groups had significant 60-month ECL (9.4% vs 6.3%, respectively, diff: 3.2%, 95% CI, -5.0% to 11.3%, P = .77). Hydrus (20.8% vs 10.6%, diff: 10.2%, 95% CI, 3.2% to 17.2%, P = .01) and CyPass (27.2% vs 10.0%, diff: 17.2%, 95% CI, 5.6% to 28.7%, P = .02) had more eyes with ECL vs controls (iStent inject 1.49X, Hydrus 1.96X, CyPass 2.72X vs controls). Mean ECD over 60 months for iStent inject was indistinguishable vs control, whereas greater ECL was observed primarily 3 months postoperative (Hydrus) or accelerated after 2 years (CyPass). No iStent inject or Hydrus subjects developed persistent corneal edema, whereas 7 CyPass-implanted eyes developed ECL-related complications. CONCLUSIONS: Through 5 years postoperative, there were no differences in proportion of eyes with significant ECL or mean ECD between the iStent inject and control groups. There was greater 5-year ECL and lower ECD in the Hydrus and CyPass groups vs controls. The Hydrus ECL rate mirrored control after 3 months; the CyPass ECL rate accelerated vs control.

Two-Year Performance and Safety Results of the MINIject Supraciliary Implant in Patients With Primary Open-Angle Glaucoma: Meta-Analysis of the STAR-I, II, III Trials.

PURPOSE: To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure. DESIGN: Meta-analysis. METHODS: At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss. RESULTS: At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%. CONCLUSIONS: This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.

Difficult decisions, filtration surgery, and the heartbreak of the numerator.

A 70-year-old man had progressive and severe glaucoma in each eye. He was intolerant to dorzolamide, brimonidine, and netarsudil. Each eye had prior selective laser trabeculoplasty (SLT) as well as phacoemulsification plus minimally invasive glaucoma surgery (MIGS) 6 years before current presentation (iStent [Glaukos Corp.] in the right eye and Cypass [Alcon Laboratories, Inc.] in the left eye). Postoperative acuities were 20/20 and 20/25 in the right and left eyes, respectively. When his left eye progressed with loss of central acuity despite peak intraocular pressures (IOPs) in the middle to upper teens, neuro-ophthalmology consultation was obtained (Figure 1JOURNAL/jcrs/04.03/02158034-202401000-00017/figure1/v/2023-12-22T124801Z/r/image-tiff). That workup included magnetic resonance imaging scan and hematologic screening, but all results were negative, and the neuro-ophthalmic consultant concluded that the vision loss was likely on the basis of glaucoma. Accordingly, a trabeculectomy was performed in the left eye achieving consistent IOPs in the range of 7 to 10 mm Hg without medications, rending the left eye stable since the filtration surgery nearly 2 years previously. The right eye continued to progress both subjectively and objectively, and on recent examination, the IOP measured 20 mm Hg and 09 mm Hg in the right and left eyes, respectively (Figure 2JOURNAL/jcrs/04.03/02158034-202401000-00017/figure2/v/2023-12-22T124801Z/r/image-tiff). Medications included timolol and latanoprostene bunod in the right eye only. Central corneal thickness was 526 µm and 527 µm in the right and left eyes, respectively. The visual acuity now measured 20/25 in the right eye and 20/250 in the left eye. The vertical cup-to-disc ratio was 0.9 in the right eye and 1.0 in the left eye. Gonioscopy revealed a wide open angle in each eye with a patent sclerostomy superiorly in the left eye. The conjunctiva and sclera were healthy and without scarring in the right eye. The bleb in the left eye was diffuse, lightly vascularized, and seidel negative. Axial length (AL) was 26.88 µm in the right eye and 26.77 µm in the left eye. The patient was in good health and was not anticoagulated. An extensive discussion ensued about the best course of action for the right eye. How would you proceed in managing definite progression in this individual's right eye, knowing that he had lost fixation in his left eye at similar pressures?

Preservative-Free versus Benzalkonium Chloride-Preserved Latanoprost Ophthalmic Solution in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3 US Clinical Trial.

Purpose: To evaluate the safety and efficacy of a preservative-free latanoprost 0.005% formulation (T2345) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) compared to benzalkonium chloride-preserved latanoprost 0.005% (BPL) formulation in the United States (US). Patients and Methods: A prospective, randomized, multicenter, observer-masked, parallel-group study enrolled 335 patients diagnosed with POAG or OHT from 31 US sites who had adequately controlled intraocular pressure (IOP; ≤18 mm Hg) with latanoprost monotherapy. After a ≥72-hour washout period, patients were randomized to T2345 (n=165) or BPL (n=170) groups. Study drugs were dosed once-daily from Day 0 to Day 84 in one or both eyes. The study eye was the eye with lower IOP at baseline. The primary efficacy measure was the between-group comparison of the mean IOP values in the study eye at each time point (8 AM, 10 AM, and 4 PM on Days 15, 42, and 84). Safety measurements included ocular and systemic treatment-emergent adverse events (TEAEs). Results: Both T2345 and BPL adequately controlled IOP with 95% CIs within 1.5 mm Hg in the study eye at all assessed time points. The percentages of patients with diurnal IOP <18 mm Hg at Day 84 were 73.1% vs 78.7% for the T2345 and BPL groups, respectively. Adverse events were generally mild-to-moderate and primarily ocular. Fewer patients in the T2345 group experienced ocular TEAEs (13.9% vs 22.5%, respectively) and TEAEs with a suspected relationship to the study medication compared with the BPL group (5.5% vs 11.8%, respectively). The most common ocular TEAEs were instillation site pain and conjunctival hyperemia. Conclusion: In patients with POAG or OHT, both T2345 and BPL maintained IOP at or below clinically meaningful values for the duration of the study. T2345 showed a favorable safety profile, with numerically lower incidences of ocular TEAEs than BPL.

New Devices in Glaucoma.

Glaucoma remains a leading cause of blindness globally. Minimally invasive treatment techniques are rapidly expanding the availability of therapeutic options for glaucoma. These include devices aimed at enhancing outflow through the subconjunctival space, Schlemm's canal, and suprachoroidal space, sustained-release drug delivery devices, and extraocular devices aiming to reduce glaucomatous progression through other novel means. In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma. Further studies are required to determine the long-term efficacy of these devices and how they will integrate into the current landscape of glaucoma management.

Surgical Augmentation of the Suprachoroidal Space: A Novel Material and Implant.

Microinvasive glaucoma surgery (MIGS) has emerged as a safer method to lower IOP with minimal impact on patient quality of life compared to traditional glaucoma surgeries. With the advent of MIGS, there has been a renewed interest in exploring the suprachoroidal route. MIGS targeting the suprachoroidal space allow for a safe reduction in IOP while sparing conjunctiva and allowing "blebless" surgery, thus avoiding bleb-related complications. This article aims to review the rationale behind the suprachoroidal MIGS procedures and the literature surrounding the efficacy and safety of a novel suprachoroidal device, the MINIject. The available literature has shown promising IOP lowering results with the MINIject implant with a potentially safer and less invasive approach than traditional glaucoma surgeries.

First-in-Human Safety Study of Femtosecond Laser Image-Guided Trabeculotomy for Glaucoma Treatment: 24-month Outcomes.

Purpose: Pilot study to evaluate adverse events and intraocular pressure (IOP)-lowering of a novel, noninvasive glaucoma procedure, femtosecond laser, image-guided, high-precision trabeculotomy (FLIGHT). Design: Prospective, nonrandomized, single-center, interventional, single-arm clinical trial. Participants: Eighteen eyes from 12 patients with open-angle glaucoma. Methods: Eighteen eyes from 12 patients underwent FLIGHT, creating a single channel measuring 500-µm wide by 200-µm high through the trabecular meshwork and into Schlemm's canal. Adverse events, IOP, and other parameters were evaluated out to 24 months. Main Outcome Measures: Outcomes were the rates and types of adverse events and the rate of postprocedure best-corrected visual acuity loss (≥ 2 lines) compared with baseline. Efficacy outcomes were reduction in mean intraocular pressure (IOP) with respect to baseline and the percentage of eyes with a ≥ 20% reduction in IOP. Results: Eighteen eyes from 12 patients were enrolled in the study; 11 patients (17 eyes) returned at 24 months. There were no serious adverse events related to the laser treatment. Well-defined channels were clearly visible at 24 months by gonioscopy and anterior segment OCT, with no evidence of closure. At 24 months, the mean IOP was reduced by 34.6% from 22.3 ± 5.5 to 14.5 ± 2.6 mmHg (P < 5e-5), with an average of 2.0 ± 1.2 hypotensive medications compared with 2.2 ± 1.1 at baseline (P = 0.22). Fourteen out of the 17 study eyes (82.3%) achieved a ≥ 20% reduction in IOP at 24 months when compared with baseline. Conclusion: The FLIGHT system demonstrated a favorable safety profile in this initial pilot study, with no device-related serious adverse events. The channels appeared patent at 24 months, indicating medium-term durability. Financial Disclosures: Proprietary or commercial disclosure may be found after the references.

All Consecutive Ab Externo SIBS Microshunt Implantations With Mitomycin C: One-Year Outcomes and Risk Factors for Failure.

PURPOSE: To present the effectiveness, risk factors for surgical failure, and adverse events over 12 months in a consecutive diverse cohort of glaucoma patients who underwent solo or combined ab externo SIBS microshunt with mitomycin C (MMC) with or without previous subconjunctival surgery. DESIGN: Retrospective, consecutive, interventional case series. METHODS: Consecutive glaucomatous eyes on maximally tolerated medical therapy received ab externo SIBS microshunt with MMC implantation as a solo or combined procedure with phacoemulsification from July 2015 to January 2020. The primary outcome was the proportion of eyes at 12-months with the following: (1) no 2 consecutive intraocular pressures (IOPs) >17 mm Hg or clinical hypotony, without (complete success) or with (qualified success) glaucoma medications; and (2) ≥20% reduction from baseline IOP. Secondary outcomes included upper IOP thresholds of 14 and 21 mm Hg with and without a 20% IOP reduction from baseline, median IOP, medications, risk factors for failure, postoperative interventions, complications, and reoperations. RESULTS: A total of 436 eyes underwent surgery; 86 (20%) combined with phacoemulsification, 127 (29%) in eyes with refractory glaucoma, and 234 (51%) stand-alone procedures in non-refractory eyes. Complete success (6-17 mm Hg with no medications) was achieved in 64.0% of combined eyes, 58.1% of refractory eyes, and 74.8% of stand-alone non-refractory eyes; and qualified success rates (6-17 mm Hg with medications) were 90.7%, 84.7%, and 92.4% of eyes, respectively. At 12 months, 67% of eyes were medication free. Significant risk factors for failure included combined procedures in refractory eyes (hazard ratio [HR] = 3.2; 95% CI = 1.4-7.4), receiving <0.4 mg/mL of MMC (HR = 2.2; 95% CI = 1.6-3.1), refractory eyes (HR = 1.7; 95% CI = 1.2-2.5), combined procedures (HR = 1.6; 95% CI = 1.0-2.5), and each additional baseline medication class (HR = 1.3; 95% CI = 1.1-1.5). Postoperative complications occurred in 31% of eyes, and more often in those receiving ≥0.4 mg/mL MMC (odds ratio [OR] = 2.2, 95% CI 1.2-3.8). Needling occurred in 12% of eyes, with significantly higher frequency in refractory eyes (23%) and combined procedures (13%) compared to stand-alone (7%; P < .001). Revisions and reoperations occurred in 4% and 1.4% of eyes, respectively. CONCLUSIONS: The 1-year follow-up data from this large and diverse cohort support promising rates of qualified and complete surgical success with decreased medication burden and few postoperative complications and interventions. Combined phacoemulsification, refractory glaucoma, and receiving <0.4mg/mL MMC were associated with reduced surgical success rates.

Toric Trifocal Intraocular Lens for Refractive Lens Exchange: A Multi-center, Multi-surgeon Large Cohort Study.

PURPOSE: To assess the outcomes of a novel toric trifocal intraocular lens (IOL) for refractive lens exchange (RLE) in a large series of eyes with corneal astigmatism. METHODS: Consecutive eyes that underwent RLE with the PanOptix Toric IOL (Alcon Laboratories, Inc) were included. Outcomes measures included postoperative distance (UDVA), 60 cm intermediate (UIVA), and 40 cm near (UNVA) uncorrected visual acuity, manifest refraction, spherical and defocus equivalent, efficacy and safety indices, and vector analyses of refractive and toric IOL accuracy. RESULTS: A total of 4,933 eyes had a median follow-up of 3 months. UDVA of 20/20 and 20/40 was obtained in 65% and 99% of eyes monocularly and 87% and 100% binocularly, respectively. UIVA at 60 cm of 20/25 and 20/40 was achieved in 70% and 99% of eyes monocularly and in 77% and 100% binocularly, respectively. UNVA at 40 cm of 20/25 and 20/40 was achieved in 85% and 96% of eyes monocularly and in 95% and 100% binocularly, respectively. A total of 67%, 89%, 97%, and 99% of eyes had a SEQ within 0.25, 0.50, 0.75, and 1.00 diopter (D) of intended target (R2 = 0.99). Postoperative refractive astigmatism of 0.50, 0.75, and 1.00 D or less was achieved in 86%, 95%, and 98% of eyes. The vector analysis correction index and index of success were 1.04 ± 0.35 and 0.41 ± 0.31 for toric IOL accuracy and 1.00 ± 0.46 and 0.36 ± 0.55 for refractive accuracy, respectively. The 3- and 12-month post-RLE excimer laser enhancement rates were 1.1% (95% CI: 0.8% to 1.4%) and 7.6% (95% CI: 6.9% to 8.3%), respectively. CONCLUSIONS: The PanOptix Toric IOL performed well for a wide range of axial lengths and corneal astigmatism in eyes that had RLE. Most patients achieved effective uncorrected binocular near, intermediate, and distance vision for daily functioning. [J Refract Surg. 2023;39(5):302-310.].

Intermediate Outcomes of the Novel 63-µm Gelatin Microstent versus the Conventional 45-µm Gelatin Microstent.

PURPOSE: To determine intermediate intraocular pressure (IOP)-lowering and adverse event profile of the 63-µm gelatin microstent (Xen63) with mitomycin C (MMC) compared with the 45-µm gelatin microstent (Xen45) with MMC. DESIGN: Single center, consecutive, retrospective cohort study. PARTICIPANTS: Eighty-four glaucomatous eyes (42 63-µm gelatin microstent and 42 45-µm gelatin microstent) with or without previous subconjunctival glaucoma surgery. METHODS: Consecutive eyes that underwent 63-µm gelatin microstent implantation with MMC from February 2020 to June 2021 were compared with eyes that underwent 45-µm gelatin microstent implantation with MMC. Standalone and combined cases with phacoemulsification were included. MAIN OUTCOME MEASURES: Primary outcome was the hazard ratio of failure of 45-µm gelatin microstent vs. 63-µm gelatin microstent eyes at 12 months, with failure defined as 2 consecutive IOPs, (1) >17 mmHg, (2) <6 mmHg with 2 lines of vision loss, or (3) <20% reduction from baseline IOP, without (complete) or with (qualified) glaucoma medications. Secondary outcomes included IOP thresholds of 14 mmHg and 21 mmHg, postoperative IOP, medications, adverse events, interventions, and reoperations. RESULTS: The complete success rate was higher in the 63-µm gelatin microstent group (59.5% vs. 28.6%, P = 0.009) at the primary IOP threshold of 6 to 17 mmHg but did not differ significantly for qualified success (66.7% vs. 45.2%, P = 0.08). The crude hazard ratio of failure of 45-µm gelatin microstent relative to 63-µm gelatin microstent was 2.28 (95% confidence interval [CI], 1.21-4.32), and the adjusted hazard ratio was 7.90 (95% CI, 2.12-29.43). 63-µm gelatin microstent eyes had significantly lower mean IOP (12.7 ± 4.8 vs. 15.5 ± 5.1 mmHg, P = 0.001) and fewer medication classes (0.6 ± 1.1 vs. 1.7 ± 1.6 medications, P = 0.0005), with the degree of reduction in IOP and medication count being significantly greater in 63-µm gelatin microstent eyes. There were 28 and 21 distinct interventions in 63-µm gelatin microstent and 45-µm gelatin microstent eyes respectively, with 11.9% of eyes undergoing needling in each group. There were 34 and 19 distinct adverse events, in 63-µm gelatin microstent and 45-µm gelatin microstent eyes, respectively, most of which were early and transient. Nine Xen63 eyes (21.4%) and 6 45-µm gelatin microstent eyes (14.3%) underwent reoperation. CONCLUSIONS: 63-µm gelatin microstent resulted in higher surgical success rates and fewer medications compared with 45-µm gelatin microstent. This was tempered by more postoperative interventions and adverse events, although most were transient. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.