Multicenter Effectiveness and Disease Stability Through 3 Years After iStentTrabecular Micro-Bypass with Phacoemulsification in Glaucoma and Ocular Hypertension.

Purpose: To evaluate 3-year safety and efficacy of two second-generation trabecular micro-bypass stents. (iStent inject ®) with phacoemulsification. Materials and Methods: This multicenter retrospective study of iStent inject implantation with phacoemulsification included data from eight surgeons across Australia. Eyes with cataract and mild to advanced glaucoma [predominantly primary open-angle (POAG), primary angle closure (PAC), or normal-tension (NTG) glaucoma] or ocular hypertension (OHT) were included. Study assessments included intraocular pressure (IOP); number of ocular hypotensive medications; proportions of eyes with 0, 1, 2, or ≥3 IOP-lowering medications; IOP ≤15 mmHg or ≤18 mmHg; visual fields (VF); retinal nerve fiber layer thickness (RNFL); central corneal thickness (CCT); intraoperative complications; adverse events; and secondary surgeries. Results: A total of 273 eyes underwent surgery and had 36-month follow-up. At 36 months versus preoperative, mean IOP decreased by 15.5% (16.4±4.6 mmHg to 13.9±3.5 mmHg; p<0.001), and 70.3% of eyes achieved IOP of ≤15 mmHg (versus 49.1% preoperatively; p<0.001). The mean medication burden decreased by 68.5% (from 1.51±1.17 to 0.48±0.89 medications; p<0.001); 71.4% of eyes were medication-free (versus 21.6% preoperatively; p<0.001), while 6.2% of eyes were on ≥3 medications (versus 22.3% preoperatively; p<0.001); 96.3% of eyes maintained or reduced medications vs preoperative. Significant IOP and medication reductions occurred across glaucoma subtypes (POAG, PAC, NTG, OHT): 13-22% for IOP (p<0.05 for all) and 42-94% for medication (p<0.05 for all). Favorable safety included few adverse events; stable VF, RNFL, and CCT; and filtering surgery in only 8 eyes (2.9%) over 3 years. Conclusion: In this multicenter cohort from 8 surgeons across Australia, significant IOP and medication reductions were sustained through 3 years after iStent inject implantation with phacoemulsification. Results were favorable across different glaucoma subtypes (including POAG, PAC, NTG, OHT), severities, and surgeons, thereby underscoring the real-world relevance and efficacy of iStent inject implantation for glaucoma treatment.

Efficient capture of high-quality real-world data on treatments for glaucoma: the Fight Glaucoma Blindness! Registry.

OBJECTIVE: To describe the development and implementation of a web-based high-quality data collection tool to track the outcomes of glaucoma treatments in routine practice. METHODS AND ANALYSIS: This is a prospective observational registry study. An international steering committee undertook an iterative structured process to define a minimum, patient-centred data set designed to track outcomes of glaucoma treatment. The outcomes were coded into a web-based programme allowing easy access for rapid data entry. Clinicians receive personal reports enabling instant audit of their outcomes. Analyses of aggregated anonymised data on real-world outcomes are analysed and periodically reported with the goal of improving patient care. RESULTS: The minimum data set developed by the international steering committee includes the following: a baseline visit captures 13 mandatory fields in order to accurately phenotype each patient's subtype of glaucoma and to allow comparison between services, and a follow-up visit includes only four mandatory fields to allow completion within 30 s.Currently, there are 157 surgeons in 158 ophthalmology practices across Australia and New Zealand who are registered. These surgeons are tracking 5570 eyes of 3001 patients and have recorded 67 074 visits. The median number of eyes per surgeon is 22 eyes with a range of 1-575. The most common glaucoma procedure, excluding cataract surgery, is iStent inject, with 2316 cases. CONCLUSION: This software tool effectively facilitates data collection on safety and efficacy outcomes of treatments for different subgroups of glaucoma within a real-world setting. It provides a template to evaluate new treatments as they are introduced into practice.

Two-Year Multicenter Outcomes of iStent inject Trabecular Micro-Bypass Stents Combined with Phacoemulsification in Various Types of Glaucoma and Ocular Hypertension.

PURPOSE: This multicenter study evaluated 2-year effectiveness and safety following implantation of two second-generation trabecular micro-bypass stents (iStent inject ®) with phacoemulsification. MATERIALS AND METHODS: This was a retrospective study of iStent inject implantation with phacoemulsification by nine surgeons across Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle/POAG, appositional angle-closure/ACG, or normal-tension/NTG) or ocular hypertension (OHT), and cataract. Evaluations included intraocular pressure (IOP); medications; proportions of eyes with 0 or ≥2 medications, reduced/stable medications versus preoperative, and IOP ≤15 mmHg; visual acuity; cup-to-disc ratio (CDR); visual fields (VF); adverse events; and secondary surgery. RESULTS: A total of 340 eyes underwent surgery and had 24-month follow-up data. At 24 months, mean IOP decreased by 16% from 16.4±4.7 mmHg preoperatively to 13.7±3.1 mmHg (p<0.001), and 77% of eyes achieved IOP of ≤15 mmHg versus 49% preoperatively (p<0.001). Mean number of medications decreased by 67% to 0.49±0.95 versus 1.49±1.20 preoperatively (p<0.001), with 74% of eyes medication-free versus 25% preoperatively (p<0.001), and 14% of eyes on ≥2 medications versus 46% preoperatively (p<0.001). Medication burden was reduced or stable in 98% of eyes versus preoperative. Stratified analyses showed significant IOP and medication reductions across glaucoma subtypes (POAG, ACG, NTG, OHT): 13-22% for IOP (p<0.01 for all) and 62-100% for medication (p<0.001 for all). Favorable safety included few adverse events; stable CDR, VF, and visual acuity; and filtering surgery in only 8 eyes (2.4%) over 2 years. CONCLUSION: This 340-eye multicenter dataset provides robust evidence of the safety and efficacy of iStent inject implantation with phacoemulsification, with significant and sustained IOP and medication reductions through 2 years. Results were similarly favorable across glaucoma subtypes (including POAG, ACG, NTG, OHT) and were attained across various glaucoma severities, clinical sites, and surgeons, highlighting the real-world versatility and utility of this treatment modality.

One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study.

PURPOSE: To assess the utility and safety of implanting two second-generation trabecular micro-bypass stents following cataract surgery in eyes with mild to advanced glaucoma or ocular hypertension (OHT). PATIENTS AND METHODS: Retrospective study of iStent®inject trabecular micro-bypass implantation with cataract surgery by five surgeons at five sites in Australia. Eyes had mild to advanced glaucoma (predominantly primary open-angle, appositional angle-closure, or pseudoexfoliative glaucoma) or OHT and cataract requiring surgery. Effectiveness measures included intraocular pressure (IOP); medication burden; and proportions of eyes with no medications, ≥2 medications, stable or decreased medications vs preoperative, and IOP ≤18 mmHg. Safety measures included visual acuity, cup-to-disc ratio (CDR), visual field (VF), complications, adverse events, and secondary surgical interventions. Patients have been followed for 12 months, and follow-up is ongoing. RESULTS: Of the 290 total eyes that underwent surgery, 165 eyes had 12-month outcomes at the time of data collection and are included in this report. In these eyes, mean Month 12 IOP reduced by 23.2% from 18.27±5.41 mmHg preoperatively to 14.04±2.98 mmHg (P<0.001), with 95.8% of eyes achieving Month 12 IOP of ≤18 mmHg vs 60.6% preoperatively. Mean number of medications at 12 months decreased by 71.5%, 0.47±0.95 vs 1.65±1.28 preoperatively; 76.4% of eyes were on zero medications vs 17.6% preoperatively (P<0.001); 14.5% of eyes were on ≥2 medications vs 46.7% preoperatively (P<0.001); and 98.2% of eyes maintained or reduced medications vs their preoperative regimen. Favorable safety included no stent-related intraoperative complications; limited and transient postoperative adverse events; and stable CDR, VF, and visual acuity. Three eyes with more advanced disease underwent additional glaucoma surgeries. CONCLUSION: iStent inject implantation with cataract surgery significantly and safely reduced medications and IOP in eyes with various types and severities of glaucoma within a multicenter, multi-provider, real-life setting.

Use of a digital infrared pupillometer to assess patient suitability for refractive surgery.

PURPOSE: To assess the role of binocular infrared dynamic pupillometry in measuring and recording the pupil size in scotopic, low mesopic, and high mesopic illumination prior to refractive surgery. SETTING: The Rosen Eye Surgery Centre, Alexandra Hospital Victoria Park, Manchester, United Kingdom. METHODS: In this prospective study, the pupil sizes of 58 patients (mean age 46 years +/- 11.7 [SD]) presenting for refractive surgery assessment were evaluated using the P2000 SA pupillometer (Procyon Instruments Ltd.). Each patient was measured at 3 illumination levels: 0.02 lux (scotopic), 0.15 lux (low mesopic), and 10.6 lux (high mesopic). At each level, 10 images were acquired by the system at 5 images per second. Both eyes were imaged at the same time, with a spatial accuracy of 0.03 mm per pixel. RESULTS: Pupillary unrest (PU) occurred at all levels of illumination. Some degree of PU amplitude was observed in both eyes of all patients. The median PU was 0.12 mm (95% confidence limits [CLs], 0.11, 0.14) in the scotopic range, 0.34 mm (95% CLs, 0.28, 0.38) in the low mesopic range, and 0.28 mm (95% CLs, 0.23, 0.30) in the high mesopic range. The degree of anisocoria varied among individuals. The median value was 0.28 mm (95% CLs, 0.21, 0.39) in the scotopic range, 0.32 mm (95% CLs, 0.26, 0.37) in the low mesopic range, and 0.16 mm (95% CLs, 0.12, 0.19) in the high mesopic range. Because of PU and anisocoria, single versus multiple binocular measurements demonstrated the possibility of errors greater than 1.0 mm in some patients. CONCLUSIONS: Patients showed an appreciable degree of pupillary motion during measurement at all levels of illumination; the motion was largest under low mesopic illumination. The 2 pupils were rarely identical. Multiple-measurement binocular pupillometry is better than single monocular measurement to gain a precise description of pupil behavior before refractive surgery.

Tracker-assisted laser in situ keratomileusis for myopia using the autonomous scanning and tracking laser: 12-month results.

OBJECTIVE: To determine the safety, efficacy, and predictability of the Autonomous scanning and tracking laser for the correction of myopia and myopic astigmatism with laser in situ keratomileusis (LASIK) procedure. DESIGN: Retrospective, noncomparative case series. PARTICIPANTS: The first 129 consecutive eyes with up to -13.00 diopters (D) of myopia and -5.00 D of astigmatism. INTERVENTION: Myopic tracker-assisted LASIK (T-LASIK) using the Autonomous Laser (Alcon Summit Autonomous, Waltham, MA) and Hansatome microkeratome (Bausch & Lomb Surgical, Bracknell, England). MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), manifest spherical equivalent (MSE), best spectacle-corrected visual acuity (BSCVA), and complications were studied. RESULTS: At 12 months, the mean MSE was -0.02 +/- 1.01 D, with 79.1% of eyes within 0.5 D and 89.9% of eyes within 1 D of the intended correction. UCVA was 20/20 or better in 71.4%, 20/25 or better in 78.5%, and 20/40 or better in 92.8% of eyes. Two eyes (1.6%) lost 2 lines and five eyes (3.8%) gained 2 lines of BSCVA. Sixteen eyes (12.4%) required retreatment to correct residual myopia or astigmatism. After retreatment, 14 of 16 eyes were within 0.5 D of emmetropia. Nine eyes (6.9%) had minor flap complications; two eyes (1.6%) had grade 2 diffuse lamellar keratitis, of which one eye had associated peripheral flap melt. One eye showed slight decentration; this eye was rolling throughout the procedure. All eyes had some dryness, with 10% severe enough to require temporary punctual occlusion with plugs. CONCLUSIONS: T-LASIK for myopic astigmatism with the Autonomous Laser is relatively safe, effective, and predictable. The tracker seems to be effective, and the complications are relatively few. Retreatment rates are acceptable and can be performed safely and effectively to improve visual outcome. The outcomes are comparable with other published data.