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.

Diagnosis of subretinal neovascularization associated with idiopathic juxtafoveal retinal telangiectasia - fluorescein angiography versus spectral-domain optical coherence tomography.

BACKGROUND: To compare ability of fluorescein angiography (FFA) and spectral-domain optical coherence tomography (SD-OCT) to diagnose subretinal neovascularization (SRNV) secondary to idiopathic juxtafoveal retinal telangiectasia (IJRT) type 2A. METHODS: Two masked observers evaluated FFA and SD-OCT images separately to diagnose the presence of SRNV in 65 eyes of 36 patients. A third masked observer diagnosed SRNV on color fundus photo. Presence of SRNV on color fundus photo was defined as presence of subretinal hemorrhage, thickening of retina, and/or visible membrane at the macula. Presence of SRNV on FFA was defined when there was hyperfluorescence in early phase with increase in intensity and size in the late phase; presence of membrane, large irregular lesion, hypofluorescence due to subretinal haemorrhage. SRNV on SD-OCT was defined as the presence of thickening of the retinal pigment epithelium-choriocapillaris complex with or without intraretinal fluid or subretinal fluid and associated with intraretinal hyperreflective area with retinal thickening. RESULTS: Interobserver agreement (Kappa) for diagnosis of SRNV on FFA and SD-OCT was 0.373 (95 % CI, 0.106-0.617) and 0.775 (95 % CI, 0.612-0.899) respectively. The sensitivity and specificity of FFA were 52.3 % and 70.0 % respectively. With regard to SD-OCT, the sensitivity and specificity were 72.7 % and 64.1 % respectively in reference to color photograph. The negative predictive value (NPV) of SD-OCT (80.6 %) was higher than FFA (73.7 %). When we considered only the presence of subretinal hemorrhage on color photograph as a confirmed diagnosis of SRNV and compared the diagnostic ability of FFA and SD-OCT, we found that the FFA had poor sensitivity (58.3 %) but a better specificity (71.8 %) than SD-OCT, which had sensitivity of 75 % and specificity of 64 % (Tables 1 and 2). However, the negative predictive value (NPV) of SD-OCT (89.29 %) was slightly better than FFA (84.85 %). CONCLUSION: Interobserver agreement between the observers was better for SD-OCT than for FFA in making the diagnosis of SRNV. SD-OCT is a better diagnostic modality than FFA for ruling out the presence of SRNV.

Reproducibility of consecutive automated telemetric noctodiurnal IOP profiles as determined by an intraocular implant.

BACKGROUND: Intraocular pressure (IOP) monitoring in glaucoma management is evolving with novel devices. We investigated the reproducibility of 24 hour profiles on two consecutive days and after 30 days of self-measurements via telemetric IOP monitoring. METHODS: Seven primary patients with open-angle glaucoma previously implanted with a telemetric IOP sensor in one eye underwent automatic measurements throughout 24 hours on two consecutive days ('day 1' and 'day 2'). Patients wore an antenna adjacent to the study eye connected to a reader device to record IOP every 5 min. Also, self-measurements in six of seven patients were collected for a period of 30 days. Analysis included calculation of hourly averages to correlate time-pairs of day 1 versus day 2 and the self-measurements vers day 2. RESULTS: The number of IOP measurements per patient ranged between 151 and 268 on day 1, 175 and 268 on day 2 and 19 and 1236 during 30 days of self-measurements. IOP time-pairs of automatic measurements on day 1 and day 2 were significantly correlated at the group level (R=0.83, p<0.001) and in four individual patients (1, 2, 6 and 7). IOP time-pairs of self-measurements and day 2 were significantly correlated at the group level (R=0.4, p<0.001) and in four individual patients (2, 5, 6 and 7). CONCLUSIONS: Twenty-four hour automatic measurements of IOP are correlated on consecutive days and, though to a lesser degree, with self-measurements. Therefore a virtual 24-hour IOP curve might be constructed from self-measurements. Both options provide an alternative to frequent in-office IOP measurements.

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.

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.

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.

Multifocal electroretinography in type 2 idiopathic macular telangiectasia.

BACKGROUND: To characterize the electroretinographic response of the macula by multifocal electroretinography (mfERG) in patients with type 2 idiopathic macular telangiectasia (MacTel). METHODS: A prospective study of mfERG in patients with type 2 MacTel was conducted from April 2009 to November 2009. mfERGs were recorded using a visual evoked response imaging system (MonElec2, Metrovision, Perenchies, France). The International Society for Clinical Electrophysiology of Vision (ISCEV) guidelines were followed. Patients with type 2 MacTel confirmed by fundus fluorescein angiography without subretinal neovascularisation were included. For recording purposes, 61 stimulus hexagonal elements were used. The first-order kernel mfERG responses were analyzed. Individual mfERG responses for the hexagons were grouped into concentric rings centered on the fovea for analysis (< 2, 5-10, 10-15 and >15°). Student's t-test and Mann-Whitney U test and linear regression analysis was performed with STATA ver 11.1 (StataCorp, College Station , TX, USA). RESULTS: Twenty eight eyes of 14 patients and 20 eyes of ten normal controls were included in the study. The mean logMAR visual acuity of the patients was 0.51 (Snellen equivalent 20/63). The mean N1 amplitude (nv/deg(2)) of patients were significantly reduced compared to controls and were as follows: 8.91 ± 14.00 vs 43.44 ± 9.55 (p < 0.0001) in less than 2°, 9.24 ± 10.47 vs 22.00 ± 3.87 (p < 0.0001) in 5-10°, 8.57 ± 10.02 vs 15.24 ± 1.89 (p < 0.0001) in 10-15°, and 7.03 ± 6.52 vs 12.47 ± 2.62 in > 15° (p < 0.001). The mean P1 amplitude (nv/deg(2)) was also significantly reduced in patients compared to controls and was as follows: 27.66 ± 37.44 vs 96.20 ± 12.41 (p < 0.0001) in less than 2°, 22.61 ± 19.38 vs 53.78 ± 9.79 (p < 0.0001) in 5-10°, 18.75 ± 20.21 vs 35.22 ± 4.16 (p < 0.001) in 10-15°, and 17.10 ± 12.54 vs 25.71 ± 3.93 (p < 0.001). The implicit time of N1 and P1 were also delayed significantly in all the rings. The mean central foveal thickness assessed by optical coherence tomography (OCT) scan was 84.78 ± 45.12 µm. There was poor correlation between mfERG amplitudes or implicit times with either the visual acuity or OCT central thickness. CONCLUSION: mfERG showed significant reduction in amplitudes and implicit times of the waveforms in patients with type 2 MacTel in all the rings, suggesting a more generalized affection of the macula. The maximum reductions were seen in the <2(o) rings. Although there was poor correlation between the visual acuity and the amplitudes a of the waveforms, mfERG is a useful investigative modality for functional assessment of macula in type 2 MacTel patients.

Measurement of intraocular temperature in glaucoma: week-day and seasonal fluctuations.

PURPOSE: To evaluate long-term intraocular temperature (IOT) variations in eyes with primary open-angle glaucoma (POAG) using an intraocular telemetric sensor. METHODS: This prospective, open-label, multicentre observational study analysed the IOT variations in 22 eyes of 22 patients with POAG. All enrolled patients underwent implantation of an intraocular pressure (IOP) sensor during cataract surgery. The telemetric system uses a built-in temperature sensor to control measured IOP for temperature. Each time a patient measures their IOP, both the IOP and IOT are recorded in the reader device. Patients were instructed to self-measure their IOP as often as desired, but at least four times daily. Recorded readings were retrieved and analysed using mixed effect models and pairwise comparisons using Bonferroni correction to assess the statistical significance of average IOT variations between each individual weekday and calendar month. RESULTS: The mean age of patients was 67.8±6.8 years and 36.4% were women. A total of 132 745 readings over 21 102 measurement-days were obtained. On average, IOT was significantly higher on Sundays (34.57°C; 95% CI 34.37 to 34.78) than on any other day of the week (p<0.001). Mean IOT on other weekdays ranged from 34.48°C to 34.51°C. Over the year, IOT followed a clear seasonal pattern, reaching its maximum in July (34.8°C; 95% CI 34.56 to 34.97) and its minimum in January (34.4°C; 95% CI 34.15 to 34.56; p<0.001). CONCLUSIONS: This study demonstrates the feasibility of continual and long-term measurement of IOT using intraocular sensors. The results show significant short-term and long-term fluctuations of IOT. Research is warranted to understand the impact of IOT variations on IOP, ocular perfusion and glaucoma progression.

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.

Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial.

AIM: To investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS). METHODS: Prospective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor's safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tonometry (GAT). RESULTS: The eyes underwent canaloplasty (n=15) or deep sclerectomy (n=9) and achieved successful implantation of the sensor. No device migration, dislocation or serious device-related complications occurred. A total of 367 comparisons were included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 1.31 mm Hg (lower limit of agreement (LoA) 7.55 mm Hg; upper LoA -4.92 mm Hg). The maximum difference of 2.5 mm Hg ±3.96 (LoA 0.30-2.29) was reached on day 10 and continuously improved to an agreement of -0.15 mm Hg ±2.28 (LoA -1.24 to 0.89) after 6 months. Accordingly, the percentage of eyes within an IOP difference of ±5 mm Hg improved from 78% (day 3) to 100% (6 months). CONCLUSIONS: After 6 months, the EYEMATE-SC sensor was safe and well tolerated, and allowed continual IOP monitoring. TRIAL REGISTRATION NUMBER: NCT03756662.

Sustainable Enhanced Sodium-Ion Storage at Subzero Temperature with LiF Integration.

Though layered sodium oxide materials are identified as promising cathodes in sodium-ion batteries, biphasic P3/O3 depicts improved electrochemical performance and structural stability. Herein, a coexistent P3/O3 biphasic cathode material was synthesized with "LiF" integration, verified with X-ray diffraction and Rietveld refinement analysis. Furthermore, the presence of Li and F was deduced by inductively coupled plasma-optical emission spectrometry (ICP-OES) and energy dispersive X-ray spectroscopy (EDS). The biphasic P3/O3 cathode displayed an excellent capacity retention of 85% after 100 cycles (0.2C/30 mA g-1) at room temperature and 94% at -20 °C after 100 cycles (0.1C/15 mA g-1) with superior rate capability as compared to the pristine cathode. Furthermore, a full cell comprising a hard carbon anode and a biphasic cathode with 1 M NaPF6 electrolyte displayed excellent cyclic stabilities at a wider temperature range of -20 to 50 °C (with the energy density of 151.48 Wh kg-1) due to the enhanced structural stability, alleviated Jahn-Teller distortions, and rapid Na+ kinetics facilitating Na+ motion at various temperatures in sodium-ion batteries. The detailed post-characterization studies revealed that the incorporation of LiF accounts for facile Na+ kinetics, boosting the overall Na storage.

Non-polar ether-based electrolyte solutions for stable high-voltage non-aqueous lithium metal batteries.

The electrochemical instability of ether-based electrolyte solutions hinders their practical applications in high-voltage Li metal batteries. To circumvent this issue, here, we propose a dilution strategy to lose the Li+/solvent interaction and use the dilute non-aqueous electrolyte solution in high-voltage lithium metal batteries. We demonstrate that in a non-polar dipropyl ether (DPE)-based electrolyte solution with lithium bis(fluorosulfonyl) imide salt, the decomposition order of solvated species can be adjusted to promote the Li+/salt-derived anion clusters decomposition over free ether solvent molecules. This selective mechanism favors the formation of a robust cathode electrolyte interphase (CEI) and a solvent-deficient electric double-layer structure at the positive electrode interface. When the DPE-based electrolyte is tested in combination with a Li metal negative electrode (50 µm thick) and a LiNi0.8Co0.1Mn0.1O2-based positive electrode (3.3 mAh/cm2) in pouch cell configuration at 25 °C, a specific discharge capacity retention of about 74% after 150 cycles (0.33 and 1 mA/cm2 charge and discharge, respectively) is obtained.

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.