EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.

PURPOSE: Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS). DESIGN: Prospective, multicenter, open-label, single-arm, interventional clinical trial. PARTICIPANTS: Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy). METHODS: An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months. MAIN OUTCOME MEASURES: Device position and adverse events. RESULTS: Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT. CONCLUSIONS: The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Phacoemulsification versus Phacotrabeculectomy in Medically Controlled Primary Angle Closure Glaucoma with Cataract in an Indian Cohort: A randomized controlled trial.

PURPOSE: To compare the outcomes of phacoemulsification with phacotrabeculectomy in primary angle closure glaucoma (PACG) eyes with medically controlled intraocular pressure (IOP). METHODS: Prospective, randomized control trial including 33 eyes of 33 patients who underwent phacoemulsification (Phaco) and 37 eyes (37 patients) who underwent phacotrabeculectomy (PT). The primary outcome measure was survival defined as IOP control (IOP ≥ 6 and ≤ 21 mmHg without antiglaucoma medications (AGM) at different time points. Secondary outcome measures were the rate of visual recovery and complications. RESULTS: The mean age in years (PT: 58.5 ± 9.8, Phaco:61.6 ± 8.9; p = 0.16), preoperative mean deviation in decibel (PT: -18.7 ± 9.3; Phaco: -16.6 ± 7.9; p = 0.32) and the mean follow up in years (PT: 2.5 ± 1.8; Phaco: 2.8 ± 2.0; p = 0.63) were similar in the two groups. The mean preoperative AGMs were more in the PT group (PT: 2.13 ± 0.97, Phaco: 1.60 ± 0.78; p = 0.01). In both the groups the survival was similar at all-time points (PT: 78% at 1-year and 52% at 5-years, Phaco: 80% at 1 year and 59% at 5 years (P = 0.82). The postoperative visual acuity in LogMAR was significantly better in the Phaco group at 1 month (PT: 0.22 ± 0.38, Phaco:0.06 ± 0.07; p = 0.02). Postoperative AGM (p = 0.68) and rate of visual field progression PT: -0.46 ± 0.41 dB/year; Phaco: -0.38 ± 0.73 dB/year; p = 0.67) were similar in both groups. One eye in PT group developed malignant glaucoma which resolved with laser hyaloidotomy and cycloplegic therapy. CONCLUSIONS: More rapid visual recovery with similar IOP control and similar visual field stability favor phacoemulsification to phacotrabeculectomy in medically controlled PACG eyes with cataract.

Short-Term and Long-Term Variability of Intraocular Pressure Measured with an Intraocular Telemetry Sensor in Patients with Glaucoma.

PURPOSE: To evaluate the short-term and long-term variability of intraocular pressure (IOP) in eyes with primary open-angle glaucoma. DESIGN: Prospective study. PARTICIPANTS: Twenty-two patients previously implanted with a sulcus-based IOP sensor (EyeMate, Implandata GmbH, Germany). METHODS: Twenty-two patients previously implanted with the EyeMate were requested to obtain at least 4 IOP measurements daily. Data were grouped according to the eye and the medication so that an eye treated with a particular medication was considered as one group, and the same eye treated with a different medication during the observation period was considered as a different group. A day was divided into 7 periods: night, midnight to 5:59 am; early, 6 am to 7:59 am; morning, 8 am to 10:59 am; noon, 11 am to 1:59 pm; afternoon, 2 pm to 5:59 pm; evening, 6 pm to 8:59 pm; and late, 9 pm to 11:59 pm. Short-term variability during a particular period was defined as the variability in IOP measurements obtained during that period on different days within 3 months of each other. Long-term variability was defined as the variability in IOP measurements obtained during a particular period on different days over a period of 1 year or more. Variability was assessed using intraclass correlation coefficients (ICCs). RESULTS: The mean age of study participants was 67.8 ± 6.8 years and 36.4% were women. The mean follow-up duration of patients was 19.2 ± 21.3 months (median, 9 months; range, 1-58 months). Overall, 92 860 IOP measurements over 15 811 measurement days were obtained and analyzed during the study period. The number of measurements obtained from each eye ranged from 1 daily to 277 daily. Intraclass correlation coefficients for short-term variability among the 7 periods during the day ranged from 0.52 (morning) to 0.66 (early). Long-term ICCs ranged from 0.29 (night) to 0.51 (late). CONCLUSIONS: Continual IOP monitoring showed that IOP has moderate short-term and high long-term variability in glaucoma patients. These findings demonstrate that single IOP measurements do not characterize day-to-day variations in IOP. Moreover, they show the importance of continual IOP monitoring in glaucoma patients.

XEN-augmented Baerveldt drainage device implantation in refractory glaucoma: 1-year outcomes.

PURPOSE: To evaluate outcomes of XEN-augmented Baerveldt drainage device implantation in refractory glaucoma and factors predicting surgical success. METHOD: All eyes undergoing XEN-augmented Baerveldt for refractory open-angle glaucoma at a tertiary glaucoma centre between January 2016 and November 2017 were retrospectively enrolled. Intraocular pressure (IOP), number of anti-glaucomatous medications and postoperative adverse events (AEs) were analysed for 1 year postoperatively. Surgical success was defined as achieving (1) an IOP ≤ 15 mmHg or (2) ≤ 18 mmHg, with or without (qualified) or without medications (complete). Any subsequent glaucoma surgery was considered failure. RESULTS: Out of 60 eyes enrolled, 12-month data were available for 41 eyes (71.4%). Mean age was 64.7 ± 23.1 years (50% female). Following surgery, IOP decreased significantly from a baseline of 29.9 ± 13.2 to 15.2 ± 6.6 mmHg (- 49.2%; P < 0.0001) at 12 months. Anti-glaucoma medications decreased from 3.0 ± 1.3 to 1.3 ± 0.9. Complete success was achieved by 14.6% of eyes using both the ≤ 15 mmHg and the ≤ 18 mmHg thresholds, and qualified success was achieved in 43.9% and 48.8%, respectively. Throughout the follow-up period, AEs were observed in 51.2% (hypotony = 24.4%; XEN blockage = 17.1%; displacement of XEN gel stent = 4.9%; hyphema = 4.9%). The 12-month success rate was significantly higher in patients who presented an IOP ≤ 10 mmHg at 1 week (58.6%, P = 0.001). Overall, 41.5% of patients required reoperation at 12 months (58.8% revision of the surgery; 41.2% transscleral cyclodestruction). CONCLUSION: XEN-augmented Baerveldt is a safe and moderately effective technique to reduce IOP and anti-glaucoma medications in refractory glaucoma. IOP at 1 week seems to be a predictor for surgical success. Nevertheless, a high proportion of patients requires reoperation.

Comparison of Scleral Tono-Pen Intraocular Pressure Measurements with Goldmann Applanation Tonometry.

SIGNIFICANCE: Measuring the intraocular pressure (IOP) on the sclera can be an alternative to conventional corneal measurement in eyes with scarred corneas. However, these measurements have to be evaluated prior in normal eyes. Our study aimed to evaluate scleral IOP using Tono-Pen and compared it with corneal Goldmann applanation measurements. PURPOSE: The aim of this study was to evaluate the ability of limbal and scleral Tono-Pen IOP readings to predict central corneal Goldmann applanation tonometry (GAT) readings in eyes with normal corneas. METHODS: In a cross-sectional study, 115 eyes of 115 patients attending a tertiary eye care center underwent GAT on the central cornea followed by Tono-Pen readings at the central cornea, at the limbus, and at the sclera. Bland-Altman plots were used to determine the agreement between different methods of IOP measurement. RESULTS: The median IOP (interquartile range) by GAT performed on the central cornea was 18 (16, 24) mmHg, and the IOP ranged from 10 to 54 mmHg. The median IOPs (interquartile range) by Tono-Pen obtained at central cornea, limbus, and sclera were 16 (13, 23), 23 (17, 28), and 33 (27, 44) mmHg, respectively. The Pearson correlation coefficient and the 95% limits of agreement between GAT readings and Tono-Pen readings at the central cornea were 0.9 (P < .001) and -4.9 to 8.74 mmHg, respectively. The correlation coefficient between GAT readings and Tono-Pen readings at the limbus and GAT readings and Tono-Pen readings at the sclera was 0.46 (P < .001) and 0.23 (P = .01), respectively. The 95% limits of agreement between these pairs of readings were -20.55 to 13.66 and -44.02 to 13.37 mmHg, respectively. CONCLUSIONS: This study showed limited ability of Tono-Pen readings obtained at the limbus and sclera to predict the central corneal GAT IOP readings in eyes with normal corneas at various IOP ranges.

Factors affecting corneal deformation amplitude measured by Corvis ST in eyes with open-angle glaucoma.

PURPOSE: To evaluate the factors affecting corneal deformation amplitude (DA) measured using Corvis ST in eyes with open-angle glaucoma. METHODS: This prospective, longitudinal study included 48 eyes with open-angle glaucoma who required additional intraocular pressure (IOP)-lowering drops. All eyes underwent a complete eye examination at baseline, including a Corvis ST, which was repeated 4-8 weeks after the change in therapy. Factors affecting the corneal biomechanics, namely the DA, were determined using mixed effect models. RESULTS: The mean age of the cohort was 65.0 ± 7.9 years. The mean IOP reduced from 23.4 ± 5.4 mmHg to 17.9 ± 5 mmHg after the change in glaucoma treatment ( P < 0.001). The DA increased from 0.89 ± 0.16 mm to 1.00 ± 0.13 mm after IOP reduction ( P < 0.001). On mixed effect model analysis, IOP (-0.02 ± 0.001, P < 0.001) and corneal pachymetry (-0.0003 ± 0.0001, P = 0.02) affected the change in the DA. CONCLUSION: IOP and corneal pachymetry affect the DA and must be accounted for when using Corvis ST to evaluate corneal biomechanics in glaucoma.

Evaluation of an offline, artificial intelligence system for referable glaucoma screening using a smartphone-based fundus camera: a prospective study.

BACKGROUND/OBJECTIVES: An affordable and scalable screening model is critical for undetected glaucoma. The study evaluated the performance of an offline, smartphone-based AI system for the detection of referable glaucoma against two benchmarks: specialist diagnosis following full glaucoma workup and consensus image grading. SUBJECTS/METHODS: This prospective study (tertiary glaucoma centre, India) included 243 subjects with varying severity of glaucoma and control group without glaucoma. Disc-centred images were captured using a validated smartphone-based fundus camera analysed by the AI system and graded by specialists. Diagnostic ability of the AI in detecting referable Glaucoma (Confirmed glaucoma) and no referable Glaucoma (Suspects and No glaucoma) when compared to a final diagnosis (comprehensive glaucoma workup) and majority grading (image grading) by Glaucoma specialists (pre-defined criteria) were evaluated. RESULTS: The AI system demonstrated a sensitivity and specificity of 93.7% (95% CI: 87.6-96.9%) and 85.6% (95% CI:78.6-90.6%), respectively, in the detection of referable glaucoma when compared against final diagnosis following full glaucoma workup. True negative rate in definite non-glaucoma cases was 94.7% (95% CI: 87.2-97.9%). Amongst the false negatives were 4 early and 3 moderate glaucoma. When the same set of images provided to the AI was also provided to the specialists for image grading, specialists detected 60% (67/111) of true glaucoma cases versus a detection rate of 94% (104/111) by the AI. CONCLUSION: The AI tool showed robust performance when compared against a stringent benchmark. It had modest over-referral of normal subjects despite being challenged with fundus images alone. The next step involves a population-level assessment.

Treatment outcomes in malignant glaucoma.

PURPOSE: To report treatment outcomes in malignant glaucoma. DESIGN: Retrospective case series. PARTICIPANTS: Twenty-eight eyes of 26 patients who were treated for malignant glaucoma between 1991 and 2009. METHODS: Malignant glaucoma was diagnosed based on the presence of a shallow or flat central and peripheral anterior chamber in the presence of patent iridotomy, with intraocular pressure (IOP) of 22 mmHg or more after any intraocular surgery. The treatment algorithm included antiglaucoma medications and cycloplegics as first-line methods; the second-line therapy in pseudophakic eyes was laser hyaloidotomy, followed by vitrectomy-hyaloidotomy-iridectomy (VHI) or transscleral cyclophotocoagulation (TSCPC). MAIN OUTCOME MEASURES: Resolution was defined as deepening of the central anterior chamber and IOP of 21 mmHg or less (on 2 successive follow-ups at least 1 week apart) with or without topical antiglaucoma medications in the absence of systemic antiglaucoma medications. RESULTS: At the diagnosis of malignant glaucoma, 5 eyes were phakic and 23 were pseudophakic. The preceding surgeries were trabeculectomy (11 eyes), cataract surgery (10 eyes), and combined cataract and glaucoma surgery (7 eyes). Mean IOP decreased from 34 ± 8.3 mmHg at presentation to 14.3 ± 5.2 mmHg at the last visit (P<0.001). Resolution of malignant glaucoma was seen in 27 eyes (27/28; 96%), 17 eyes resolved with 1 intervention, and 10 eyes required repeat procedures. Of the 27 eyes whose disease resolved, this result was achieved in 4 eyes with medical treatment, in 7 pseudophakic eyes with laser hyaloidotomy, in 4 eyes with VHI, and in 12 eyes with TSCPC. The median duration of follow-up was 192 days (interquartile range, 35-425 days). There was no difference in the visual acuity at presentation and at the final visit in 14 eyes. Eight eyes gained 2 lines or more and 6 eyes lost 2 lines or more of visual acuity. CONCLUSIONS: Malignant glaucoma can be managed successfully by appropriate and timely interventions. Medical treatment was beneficial in phakic eyes, laser hyaloidotomy was beneficial in pseudophakic eyes, and vitrectomy and TSCPC were beneficial in refractory cases. A stepladder approach to treatment was successful (96%) in this series. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Corneal thickness in keratoconus: comparing optical, ultrasound, and optical coherence tomography pachymetry.

PURPOSE: To compare the central and peripheral pachymetry measurements determined using Orbscan IIz (Bausch & Lomb, Rochester, NY), Visante optical coherence tomography (OCT; Carl Zeiss Meditec, Dublin, CA), and RTVue OCT (Oculus Technologies, Wynwood, WA) with ultrasound pachymetry in eyes with established keratoconus and to evaluate the agreement between them. DESIGN: Evaluation of diagnostic technologies. PARTICIPANTS: One hundred six eyes of 67 consecutive patients with a clinical diagnosis of keratoconus ranging in age from 12 to 40 years. METHODS: Central corneal thickness (CCT) was determined by all the 4 techniques. Peripheral corneal thicknesses were determined using Orbscan IIz, Visante OCT, and RTVue at 8 points (superior, inferior, temporal, nasal, superior-temporal, inferior-temporal, superior-nasal, and inferior-nasal) all in the 5.0- to 7.0-mm arcuate zone. MAIN OUTCOME MEASURES: Central and peripheral keratoconus thickness. RESULTS: Ultrasound pachymetry determined significantly higher CCT values than Orbscan IIz (P<0.001), Visante (P<0.001), and RTVue (P = 0.037), with a mean ± standard deviation difference of 14±3 µm, 13±2 µm, and 5±3 µm, respectively. The mean CCT difference was minimal (1±3 µm; P = 0.69) between the Orbscan IIz and Visante. A strong correlation was found (r>0.80) between all the CCT measurement techniques. Orbscan IIz significantly overestimated the peripheral thickness compared with the rest, and the mean differences ranged between 21 and 60 µm. Mean peripheral thickness differences between RTVue and Visante OCT always remained less than 20 µm. Weak correlations and larger limits of agreement were found between the techniques in thinner and peripheral zones. CONCLUSIONS: Orbscan IIz, Visante, RTVue, and ultrasound pachymetry show high correlation, although Orbscan IIz and Visante significantly underestimated CCT measurements compared with ultrasound pachymetry in keratoconus. Orbscan IIz significantly overestimated peripheral corneal thickness compared with RTVue and Visante.

XEN 45 Gel Stent Implantation in Open Angle Glaucoma: 5-Year Results of a Prospective Study.

PRCIS: XEN 45 Gel Stent is safe and effective for 3 years. The study results provide useful insight into the outcome of XEN 45 Gel Stent surgery over 5 years in daily clinical practice. PURPOSE: To evaluate 5-year outcomes of XEN 45 gel stent implantation (XEN) in patients with open angle glaucoma. METHODS: This is a prospective, single-center, interventional study. XEN implantation either alone (XEN) or combined with phacoemulsification (Phaco + XEN) was performed on 170 consecutive eyes (126 patients) with uncontrolled intraocular pressure (IOP) or disease progression despite medical treatment. "Complete" surgical success at 60 months was defined as unmedicated IOP ≤15 mm Hg and a relative IOP reduction ≥20% from medicated baseline, while "qualified" success allowed fewer ocular hypotensive medications than at baseline. Other definitions of success with various IOP targets were also analyzed. Secondary outcomes included mean IOP and IOP-lowering medication changes and rates of reoperations. RESULTS: Mean age was 78.1±9.2 years, and 70.3% were female. Mean medicated IOP decreased from 19.8±7.7 mm Hg [19.6±7.1 (XEN) vs. 19.8±7.0 mm Hg (Phaco+XEN)] at baseline to 12.6±3.1 mm Hg [12.5± 3.1 (XEN) vs. 12.6±3.1 (Phaco+XEN)] at 5 years (-37.0%; P < 0.001). Medications decreased from 2.0±1.3 [2.0±1.3 (XEN) vs. 2.0±1.3 (Phaco+XEN)] to 0.8±1.1 [0.8±1.1 (XEN) vs. 0.8±1.1 (Phaco + XEN)] (-60%; P <0.001). Needling was performed in 84 eyes (49%), and 19.4% underwent a secondary surgical intervention. Complete success at 3 years was a strong predictor of success at 5 years (odds ratio: 3.06, P <0.01), while needling was associated with higher rates of failure (odds ratio: 3.6, P <0.01). CONCLUSIONS: At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction. Success at 3 years is a predictor of success at 5 years. Needling correlates with higher failure rates.

Agreement of a Novel Artificial Intelligence Software With Optical Coherence Tomography and Manual Grading of the Optic Disc in Glaucoma.

PRCIS: The offline artificial intelligence (AI) on a smartphone-based fundus camera shows good agreement and correlation with the vertical cup-to-disc ratio (vCDR) from the spectral-domain optical coherence tomography (SD-OCT) and manual grading by experts. PURPOSE: The purpose of this study is to assess the agreement of vCDR measured by a new AI software from optic disc images obtained using a validated smartphone-based imaging device, with SD-OCT vCDR measurements, and manual grading by experts on a stereoscopic fundus camera. METHODS: In a prospective, cross-sectional study, participants above 18 years (Glaucoma and normal) underwent a dilated fundus evaluation, followed by optic disc imaging including a 42-degree monoscopic disc-centered image (Remidio NM-FOP-10), a 30-degree stereoscopic disc-centered image (Kowa nonmyd WX-3D desktop fundus camera), and disc analysis (Cirrus SD-OCT). Remidio FOP images were analyzed for vCDR using the new AI software, and Kowa stereoscopic images were manually graded by 3 fellowship-trained glaucoma specialists. RESULTS: We included 473 eyes of 244 participants. The vCDR values from the new AI software showed strong agreement with SD-OCT measurements [95% limits of agreement (LoA)=-0.13 to 0.16]. The agreement with SD-OCT was marginally better in eyes with higher vCDR (95% LoA=-0.15 to 0.12 for vCDR>0.8). Interclass correlation coefficient was 0.90 (95% CI, 0.88-0.91). The vCDR values from AI software showed a good correlation with the manual segmentation by experts (interclass correlation coefficient=0.89, 95% CI, 0.87-0.91) on stereoscopic images (95% LoA=-0.18 to 0.11) with agreement better for eyes with vCDR>0.8 (LoA=-0.12 to 0.08). CONCLUSIONS: The new AI software vCDR measurements had an excellent agreement and correlation with the SD-OCT and manual grading. The ability of the Medios AI to work offline, without requiring cloud-based inferencing, is an added advantage.

Rotational autokeratoplasty in pediatric patients for nonprogressive paracentral corneal scars.

OBJECTIVE: To report the outcomes of ipsilateral rotational autokeratoplasty (RAK) for nonprogressive paracentral corneal opacities in children <16 years of age. DESIGN: Retrospective, consecutive, interventional case series. PARTICIPANTS: Thirty-three eyes of 33 children aged <16 years undergoing RAK for nonprogressive paracentral scars. METHODS: Medical records were retrospectively reviewed for the primary etiology of corneal opacity, time of onset, duration of opacity, preoperative visual acuity, formula used for calculation of trephine size, size of the trephine used, and duration of follow-up. Any intraoperative and early and late postoperative complications were noted for all patients. Postoperative visual acuity and astigmatism were noted. Visual acuity was converted to logarithm of the minimum angle of resolution units for analysis. MAIN OUTCOME MEASURES: Primary outcome was postoperative visual acuity. Graft clarity and complications were analyzed as secondary outcomes. RESULTS: The mean age at surgery was 7.2 ± 3 .9 months. The mean follow-up duration was 27 ± 37 months. The commonest etiology of corneal opacity was trauma (62.5%), followed by resolved microbial keratitis (21.9%). Postoperative visual acuity (1.25 ± 0.84) was significantly better (P<0.001) than preoperative visual acuity (2.05 ± 0.96). The mean astigmatism at last visit was 4.04 ± 2.21 diopters. Postoperative visual acuity was better in older children (ß = -0.01; P = 0.03) and had a shorter delay in presentation (ß = 0.02; P = 0.05). At the last follow-up, the graft was clear in 27 cases (81.25%). The cumulative probability of graft survival was 85% at 2 years and 65% at 5 years. Complications included wound leak in 4 eyes, secondary glaucoma in 2 eyes, graft infiltrate and traumatic dehiscence in 1 eye each. CONCLUSIONS: Rotational is a autokeratoplasty viable alternative surgical option to allogenic keratoplasty. Graft survival at 2 years seems to be better than allogenic keratoplasty. Younger age and delay in presentation contribute to poorer visual outcomes after surgery. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article.

Point-wise variability of threshold sensitivity of 24-2 and 10-2 visual fields.

PURPOSE: To evaluate point-wise variability of threshold sensitivity at different test locations on 24-2 and 10-2 visual field (VF). MATERIALS AND METHODS: Electronic medical records of patients seen at a tertiary eye care center were screened to include those with at least 3 reliable VF with glaucomatous defects involving fixation on 24-2 and confirmed on 10-2 test strategy. Ninety eyes of 90 patients were categorized into 3 severity groups based on mean deviation (MD on 24-2) test strategy; MD<-6 dB and >-12 dB, <-12 dB and >-20 dB and <-20 dB and >-30 dB. Variability of threshold sensitivity at all topographical test locations in central (ring 1), mid-peripheral (ring 2), peripheral rings on 24-2 VF test strategy (ring 3), and central (ring 4) and paracentral (ring 5) on 10-2 VF test along with variability of visual field index and central field index were calculated by multilevel mixed effects model. RESULTS: Central ring1 on 24-2 and ring 4 on 10-2 showed higher variability (>10 dB) than peripheral ring 2, 3, and 5. Seventy-three eyes were adjudged as stable and 17 as progressing in this cohort. The average ring and point-wise variability was higher in stable eyes (2-6 dB) across all glaucoma severities. Across severity, variability was seen to decrease with increasing severity with minimal variability in point-wise threshold sensitivity beyond MD <-20 dB. CONCLUSION: Central test points/ring on 24-2 and 10-2 with greater threshold variability suggests that status of the eye, severity and topographical location of test points should be incorporated into conventional progression algorithms to predict true glaucoma progression.

Changes in peripapillary and macular vascular density after laser selective trabeculoplasty: an optical coherence tomography angiography study.

OBJECTIVES: To determine the effect of laser trabeculoplasty on peripapillary retinal nerve fibre layer thickness (RNFL), fovea avascular zone (FAZ), peripapillary and macular vessel density (VD) in glaucoma using with optical coherence tomography angiography (OCT-A). METHODS: This was a prospective observational study performed at the Glaucoma Research Centre, Montchoisi Clinic, Lausanne, Switzerland. Thirty-seven eyes with primary open-angle glaucoma from 21 patients were included. Optical coherence tomography angiography (OCT-A) scans were performed before laser trabeculoplasty and at 2 and 6 months after the procedure. AngioVue AngioAnalytic (Optovue Inc, Fremont, CA, USA) software was used to analyse the RNFL, FAZ, peripapillary and macular VD. Changes were analysed using mixed models, controlling for intraocular pressure (IOP) and signal strength index (SSI) variations. RESULTS: Mean IOP decreased from 18.5 (±3.7) mmHg at baseline to 15.6 (±2.7) mmHg after 2 months (-15.3%; p < 0.001). No significant changes in RNFL thickness were noted following laser trabeculoplasty. Changes in peripapillary VD were mostly nonsignificant. Parafoveal (p = 0.001) and perifoveal VD (p = 0.025) significantly increased at 2 months, before reverting to near-baseline values at 6 months. No significant changes were observed in foveal parameters. Retinal nerve fibre layer thickness (RNFL) and VD changes were independent from IOP, but SSI had a significant influence on VD. CONCLUSIONS: Following laser trabeculoplasty, peripapillary and macular VD temporarily increased before returning to near-baseline values by 6 months. No correlation was found between microvascular fluctuations and IOP, and no significant effect of laser trabeculoplasty on VD or RNFL was observed at 6 months despite persistent IOP reduction. Further research is warranted to understand its exact causes and clinical relevance.

Trabeculectomy with Mitomycin-C in Post-Traumatic Angle Recession Glaucoma in Phakic Eyes With no Prior Intraocular Intervention.

PURPOSE: : To evaluate the outcomes of primary trabeculectomy with mitomycin-C (trab MMC) in phakic eyes with post-traumatic angle recession glaucoma with no prior intraocular surgeries. METHODS: : We included 32 phakic eyes of 32 patients who underwent trab MMC between January-2002 and December-2017. Complete success was IOP between 6 and 21 mm Hg without anti-glaucoma medications (AGM) and failure was when IOP >21 mm Hg with AGM or need for additional intervention for IOP control or loss of light perception. RESULTS: : Thirty-two eyes of 32 subjects with a mean age (± standard deviation) of 30.6 ± 12.6 years were included. The majority were male (97.6%) and the major cause of blunt trauma were sports injury in 28/32 eyes (88%) and 24/32 eyes (75%) had >180-degree angle recession. The Median (interquartile range) follow-up duration was 1.3 years (0.3,3.5). There was significant IOP reduction at 1-year postoperatively (34 (28,40) to 13 (12,16) mm Hg; p < .001). The median postoperative AGM at 1-year was significantly less (4 (3,4) to 0; p < .001) with stable Log MAR visual acuity (p = .24). The complete survival of trab MMC was 88% at 1 year and was 77% from 2 to 5 years. Complications were intraoperative vitreous prolapse needing limited vitrectomy in two eyes and postoperative choroidal detachment in two eyes that resolved with conservative management. The contralateral eyes of three patients (9.7%) developed elevated IOP during the follow-up period. CONCLUSION: : Trabeculectomy with mitomycin-C in phakic eyes with traumatic angle recession glaucoma showed good safety and efficacy in the medium-term follow-up. The contralateral fellow eye needs monitoring for glaucoma in these patients.

Outcomes of Deep Sclerectomy following Failed XEN Gel Stent Implantation in Open-Angle Glaucoma: A Prospective Study.

Background: The purpose of this study is to evaluate the outcome of deep sclerectomy (DS) as a secondary procedure following failed ab-interno XEN gel stent implantation in patients with open-angle glaucoma. Methods: Prospective, single-center, non-randomized, interventional study. Consecutive eyes that underwent mitomycin C (MMC) augmented XEN gel stent surgery, with uncontrolled intraocular pressure (IOP) or signs of disease progression, were included to undergo MMC-augmented DS. Primary efficacy outcome was surgical success, defined as complete when the unmedicated IOP was 12 mmHg or less, or 15 mmHg or less and 20% lower than at the timing of XEN failure and defined as qualified when the IOP fulfilled the same conditions with fewer medications than before deep sclerectomy. Secondary measures were mean reduction in IOP and in the number of medications, and the rates of complications. Results: Seventeen eyes were enrolled with a mean age of 72.1 ± 8.2 years (66.7% women). The mean follow-up was 20.1 ± 4.9 months, with more than 12-month data available from 15 eyes. Following DS, IOP decreased significantly from 22.6 ± 5.3 mmHg to 12.3 ± 5.5 (45.6%; p < 0.001). Antiglaucoma medications dropped from 1.1 ± 0.9 to 0.3 ± 0.7. Complete success was obtained in 40% of eyes using the threshold of 12 mmHg or less and a 20% decrease of IOP, and in 60% using the 15 mmHg or less threshold. Adverse events were observed in 20% of eyes (bleb leakage (13.3%); hypotony (6.7%)). No cases of choroidal detachment or hypotony maculopathy were reported. Conclusions: Failed XEN gel stent implantation does not seem to negatively affect the safety and efficacy of subsequent deep sclerectomy surgery.

Bilateral Nonpenetrating Deep Sclerectomy: Difference in Outcomes Between First- and Second-Operated Eyes at 24 Months.

BACKGROUND/AIM: The aim of this study was to assess the difference in outcome between the first-operated and the second-operated eyes after nonpenetrating deep sclerectomy (DS), and to identify potential success predictors for the second eye. METHODS: This single-surgeon, retrospective study analyzed the outcomes of all bilateral nonsimultaneous DS with at least 24 months of follow-up. Its main outcome measure was surgical success, defined as unmedicated intraocular pressure (IOP) ≤15 mm Hg associated with a relative reduction ≥20%. RESULTS: In all, 104 eyes of 52 patients who underwent bilateral (standalone or combined) DS, within a mean of 344.3±526.3 days of each other, were analyzed. Postoperatively, the mean medicated IOP decreased from 20.7±7.9 (first-operated eyes) and 19.3±6.6 mm Hg (second-operated eyes) at baseline (P=0.107) to 13.8±4.8 [(-33.3%; P<0.001) first-operated eyes) and 12.7±3.8 mm Hg [(-34.2%; P<0.001) second-operated eyes] after 2 years (P=0.619). Postoperative IOP and treatment reduction, respectively, showed fair (r=0.53) and good (r=0.71) levels of correlation between fellow eyes. The rates of complete success were comparable between first-operated and second-operated eyes (32.7% and 40.4%, respectively; P=0.364). At 2 years, among patients whose first-operated eyes were considered a success, 82.4% of surgeries in second eyes were successful (P=0.001). The odds ratio of a second-operated eye experiencing complete success were 6.32 (P=0.011) if the first-operated eye experienced complete success. CONCLUSIONS: The present study demonstrated a strong association between first-operated and second-operated eyes after DS, in terms of surgical outcomes and IOP reduction. In effect, surgical success in the first-operated eye increases the odds of success in the second eye by 6-fold.

Outcomes of trabeculectomy in eyes with refractory acute primary angle-closure in Indian eyes.

PURPOSE: To report the outcomes of trabeculectomy in eyes with refractory acute primary angle-closure attack. METHODS: Patients with acute primary angle-closure attack and who underwent trabeculectomy for medically uncontrolled intraocular pressure within 2 months of presentation were retrospectively analyzed. Primary outcome was intraocular pressure (IOP). Secondary outcome measures were visual acuity, number of antiglaucoma medication (AGM), complications, and risk factors for failure of trabeculectomy. RESULTS: Thirty-five eyes of 31 patients with median (interquartile range) follow-up of 3 (0.5, 9) years were included in the study. Median age at presentation was 55 (47, 60) years. Median duration of symptoms at presentation was 10 (4, 16) days and median time from presentation to surgery was 13 (6, 25) days. Median IOP reduced from 42 (36, 46) to 13 (12, 16) mmHg (P < 0.001) and median number of AGM reduced from 3 (1, 3) to 0 (0, 0) after trabeculectomy at the end of 1 year. The probability of complete and qualified success was 88% (95% confidence interval [CI]: 72%-95%) and was 97% (95% CI: 81%-99%) at 1 year, respectively. Failure was noted in six eyes. Subsequent cataract surgery was needed in 13 eyes (37%) with a median duration from trabeculectomy being 6.75 (1, 11) years. None of the preoperative, intraoperative, or postoperative factors tested were associated with failure (P > 0.10 for all associations on Cox proportional hazard regression analysis). CONCLUSION: In medically unresponsive cases of acute primary angle-closure attack, primary trabeculectomy seems safe and effective in Indian eyes.

Progressive Vessel Density Reduction on OCT Angiography in Glaucoma Eyes with Disc Hemorrhages.

PURPOSE: To identify longitudinal changes in peripapillary and parafoveal vessel density (VD) measured by OCT angiography (OCTA) in primary open-angle glaucoma (POAG) eyes with disc hemorrhages (DHs). DESIGN: Prospective cohort study conducted from August 2016 through August 2020 PARTICIPANTS: Eighteen Asian-Indian participants with POAG (18 eyes) who sought treatment at the clinic with a single DH in the peripapillary region were recruited consecutively. METHODS: The study was conducted at a tertiary eye care center. All participants who were recruited underwent a baseline OCT and OCTA, which were repeated every 4 to 6 months. MAIN OUTCOME MEASURES: Peripapillary VD and retinal nerve fiber layer (RNFL) thickness, parafoveal VD and ganglion cell-inner plexiform layer (GCIPL) thickness in the DH sector, and the corresponding mirror-image sector across the horizontal meridian (control) were evaluated over time using linear mixed-effects models. RESULTS: The baseline average RNFL thickness was 79 ± 9 µm. Mean duration of follow-up was 2.6 ± 0.7 years. In the DH sector, all VD and structural parameters showed a significant negative slope (P < 0.01). In the control sector, the slopes of the structural parameters (RNFL and GCIPL thickness) were not significant (P > 0.05), but the rate of change of the peripapillary and parafoveal VDs were significant (P < 0.01). The rate of change of peripapillary VD was greater in the DH sector compared with the non-DH sector (-2.86 ± 0.6%/year vs. -1.71 ± 0.7%/year; P < 0.01). However, the parafoveal VD slopes did not differ significantly between DH and control sectors (-2.9 ± 0.17%/year vs. -2.8 ± 0.8%/year; P = 0.51). CONCLUSIONS: Eyes with POAG harboring a DH showed not only progressive RNFL and GCIPL loss in the DH sector, but also progressive peripapillary and parafoveal VD reduction in the DH and non-DH regions as documented on OCTA.