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.

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.

Goniowash: a new surgical approach combined with cataract surgery to lower intraocular pressure in pseudoexfoliation syndrome.

PURPOSE: Pseudoexfoliation syndrome is common in elderly patients and is associated with intraocular pressure elevation. Goniowash is a novel surgical technique to remove pseudoexfoliation material from the irido-corneal angle to decrease intraocular pressure. We assessed the long-term efficacy of Goniowash on relevant parameters in patients with pseudoexfoliation syndrome, after cataract surgery. METHODS: The study enrolled 122 patients with pseudoexfoliation syndrome, who underwent routine cataract surgery combined with Goniowash. Best-corrected visual acuity, intraocular pressure and medication status were recorded in study participants during 5 years of follow-up. RESULTS: Data from 190 eyes (122 patients of average age 73.8 ± 7.7 years) were assessed. Mean best-corrected visual acuity increased from 0.60 to 1.0 (p < 0.001) one year after surgery and remained stable throughout the follow-up. Average intraocular pressure decreased from 26.4 ± 7.3 mmHg pre-operatively to 15.9 ± 3.0 mmHg post operatively at one year (p < 0.001), 16.1 ± 3.3 mmHg (p < 0.001) at 3 years and 16.8 ± 2.9 (p < 0.001) at 5 years. Mean number of ocular hypotensive medications decreased from 1.5 ± 0.8 pre-operatively to 0.4 ± 0.7 post-operatively (75% reduction) (p < 0.001). No unexpected and severe adverse events related to the surgical procedure were reported. CONCLUSIONS: Goniowash combined with cataract surgery provides stable and long-lasting reduction of intraocular pressure and hypotensive medications. It is a safe procedure and may be an alternative for patients with pseudoexfoliation syndrome and elevated intraocular pressure.

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.

Acute emotional stress as a trigger for intraocular pressure elevation in Glaucoma.

BACKGROUND: Stress-induced activation of the sympathetic nervous system leads to a cascade of metabolic reactions. Emotional stress is a more specific form of stress in which the stressor is a psychological response to a situation subjectively perceived as traumatic. Stress hormones can have a wide range of effects on the body, however, it is still unclear if and how it can affect ophthalmic physiology. This report presents a case of severe ocular hypertension in which emotional stress was the only cause elicited, and explores potential aggravating factors. CASE PRESENTATION: A 78-year-old, personality type A, lady with a history of pseudo-exfoliative glaucoma presented with an acute asymmetrical raise in intraocular pressure (IOP) immediately following a family breakdown. Her IOP had previously remained stable following a deep sclerectomy in the right eye and an Ex-PRESS shunt in the left eye. Her examination was entirely normal otherwise, with a patent filtration and diffuse bleb as confirmed with anterior segment OCT imaging. Near-normalisation of her IOP was observed within 24 h, concomitantly with the reduction of her stress levels. No other cause for the transient acute hypertensive episode were found. CONCLUSIONS: This case report suggests that acute emotional stress could severely affect IOP in patients suffering from glaucoma. This could be important when looking after glaucoma patients. It would also suggest that the personnality types, and the emotional and social context are more factors to take into account in glaucoma studies. These observations are based on a single case report and would need to be verified on a larger scale.

Ambulatory 24-h intraocular pressure monitoring in the management of glaucoma.

PURPOSE OF REVIEW: To review current status and future of ambulatory 24-h intraocular pressure monitoring. Despite important advances in the diagnosis and management of glaucoma during the last decade, the fundamental understanding of intraocular pressure, its only modifiable risk factor, remains elusive. The current practice of single intraocular pressure measurements during a clinic visit does not adequately reflect the variability of intraocular pressure throughout the 24-h day. RECENT FINDINGS: There has been considerable progress recently with the prototype and commercial introduction of continuous 24-h intraocular pressure monitoring devices. Implantable intraocular pressure sensors have the advantage to directly measure intraocular pressure over many months and years, whereas temporary (contact lens based) approaches provide a noninvasive alternative for repeated 24-h periods. This review provides an overview of implantable devices as well as a critical assessment of a 24-h contact lens sensor. SUMMARY: Recent advances in microelectromechanical systems and nanoelectromechanical systems have enabled the development of 24-h intraocular pressure monitoring devices. Once these technologies have shown their safety and efficacy, larger questions as to the data interpretation and handling will arise. It is likely that the use of 24-h intraocular pressure monitoring will herald fundamental changes in our understanding and management of glaucoma.

Effect of glaucoma medications on 24-hour intraocular pressure-related patterns using a contact lens sensor.

BACKGROUND: The aim of this article was to study the circadian intraocular pressure (IOP)-related effects of ocular hypotensive medications using a contact lens sensor (CLS). DESIGN: This is a university-based prospective, randomized, crossover trial. PARTICIPANTS: A total of 23 patients with primary open-angle glaucoma participated. METHODS: Patients underwent ambulatory recording of IOP-related patterns for 24 h in one eye during 3 monthly sessions using a CLS. Patients were untreated in session 1 (S1), were randomized to one of four classes of glaucoma drops for S2 and had a prostaglandin analogue add-on for S3. MAIN OUTCOME MEASURES: Changes in IOP-related patterns were defined using (i) slopes from wake/sitting to sleep/supine; (ii) cosinor rhythmometry modelling; and (iii) area under receiver operating curve (AUC) of sleep period. RESULTS: Mean patient age was 63.8 ± 11.8 years. Positive linear slopes were seen from wake/sitting to sleep/supine at S1 (17.1 ± 14.2 mVeq/h) and S2 (5.5 ± 23.9 mVeq/h) and negative slopes at S3 (-1.9 ± 29.4 mVeq/h) (S1-S2, P = 0.01; S1-S3, P = 0.02). In the prostaglandin group, slopes changed significantly with introduction of drops (S1-S2, P < 0.024), whereas they did not in a mixed group combining the three other classes (S1-S2, P = 0.060). Overall, cosinor amplitudes were 98.4 ± 46.5 mVeq (S1), 113.0 ± 35.6 mVeq (S2) and 109.6 ± 58.3 mVeq (S3) (S1-S2, P = 0.23; S1-S3, P = 0.66; S2-S3, P = 0.93). AUC were 91.8 ± 63.0 mVeq (S1), 76.3 ± 102.7 mVeq (S2) and 19.9 ± 135.8 mVeq (S3). Differences between sessions were not statistically significant (S1-S2, P = 0.541; S1-S3, P = 0.083; S2-S3, P = 0.092). CONCLUSIONS: Prostaglandin analogues, but not other medications, seem to flatten the IOP-related increase at transition of the wake/sitting to the sleep/supine period, but do not seem to have an effect on acrophase and amplitude.

Twenty-four-hour intraocular pressure patterns in patients with thyroid eye disease.

BACKGROUND: To prospectively investigate the safety, tolerability and 24-h intraocular pressure (IOP) patterns in patients with thyroid eye disease (TED) using a contact lens sensor (CLS). DESIGN: Prospective study. PARTICIPANTS: Ten patients with established TED. METHODS: Ten eyes of 10 patients were prospectively evaluated in an ambulatory 24-h IOP monitoring session using the CLS (Sensimed AG, Lausanne, Switzerland). Patients pursued daily activities, and sleep behaviour was uncontrolled. MAIN OUTCOME MEASURES: Incidence of adverse events (AEs) and tolerability (scale of 0-10, increasing intolerance) were assessed. IOP patterns were evaluated using a cosinor rhythmometry model, and linear regression slopes were constructed for the transition from wake/sitting (W/S) to sleep/supine (S/S) and vice versa. RESULTS: Mean age was 61.8 ± 21.6 years, and 90% of patients were female. Main AEs were blurred vision (50%), conjunctival hyperaemia (100%) and superficial punctate keratitis (20%). Tolerability of the lens was found to be 1.5 ± 0.7. Positive linear slopes of the CLS signal from wake to sleep were detected (18.0 ± 43.8 arbitrary units [a.u.]; P = 0.254), whereas at the transition from S/S to W/S a significant decrease (-62.9 ± 56.8 a.u.; P = 0.010) was found. Five patients (50%) had a significant nocturnal/sleep acrophase with the peak occurring at 6:30 a.m. The mean amplitude of the 24-h curves was 102.2 ± 52.6 a.u. CONCLUSIONS: In patients with TED, the CLS provides a safe and well-tolerated approach to 24-h IOP monitoring. After modelling the 24-h IOP curves, TED patients were found to have a morning acrophase.

Predictive biomarkers of intra-ocular pressure decrease after cataract surgery associated with trabecular washout in patients with pseudo exfoliative glaucoma.

To investigate biomarkers of intra-ocular pressure (IOP) decrease after cataract surgery with trabecular washout in pseudo-exfoliative (PEX) glaucoma. A single-center observational prospective study in PEX glaucoma patients undergoing cataract surgery with trabecular washout (Goniowash) was performed from 2018 to 2021. Age, gender, visual acuity, IOP, endothelial cell count, central corneal thickness, medications, were collected over 16-month follow-up. Multivariable binomial regression models were implemented. 54 eyes (35 subjects) were included. Mean preoperative IOP (IOPBL) was 15.9 ± 3.5 mmHg. Postoperative IOP reduction was significant at 1-month and throughout follow-up (p < 0.01, respectively). IOPBL was a predictive biomarker inversely correlated to IOP decrease throughout follow-up (p < 0.001). At 1 and 12 months of follow-up, IOP decrease concerned 31 (57.4%) and 34 (63.0%) eyes with an average IOP decrease of 17.5% (from 17.6 ± 3.1 to 14.3 ± 2.2 mmHg) and 23.0% (from 17.7 ± 2.8 to 13.5 ± 2.6 mmHg), respectively. Performance (AUC) of IOPBL was 0.85 and 0.94 (p < 0.0001, respectively), with IOPBL threshold ≥ 15 mmHg for 82.1% and 96.8% sensitivity, 84.2% and 75.0% specificity, 1.84 and 3.91 IOP decrease odds-ratio, respectively. All PEX glaucoma patients with IOPBL greater than or equal to the average general population IOP were likely to achieve a significant sustainable postoperative IOP decrease.

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.

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.

Long-Term Astigmatism after Intraocular Pressure Sensor Implantation and Nonpenetrating Glaucoma Surgery - EYEMATE-SC Trial.

PURPOSE: To investigate the long-term astigmatism after combined non-penetrating glaucoma surgery (NPGS) and implantation of the first miniaturized suprachoroidal intraocular pressure (IOP) sensor EYEMATE-SC. SETTING: The study was conducted in five medical centers in two different countries. DESIGN: Retrospective multicenter clinical study. METHODS: Astigmatism of patients instrumented with the EYEMATE-SC IOP sensor was assessed over a follow-up period of three years. Refraction and corrected distance visual acuity (CDVA) were obtained preoperatively, after 6 months, 1, 2, and 3 years. A canaloplasty-operated patient cohort served as control. Astigmatism was evaluated using 3-dimensional power vector analysis involving the spherical equivalent M, and the Jackson crossed cylinder projections J0 and J45. Exclusion criteria included neovascular and angle-closure glaucoma, myopia, axial length outside 22 to 26 mm, other ocular diseases, prior glaucoma surgery, other ocular surgery within 6 months (cataract surgery within 3 months) prior to NPGS, serious generalized conditions, and other active medical head/neck implants. RESULTS: Multivariate analysis indicated no changes in astigmatism along the observation period in both the EYEMATE-SC (n = 24) and the canaloplasty (n = 24) group (P > 0.05 or nonsignificant after Bonferroni correction). Astigmatism was unchanged between the EYEMATE-SC and the canaloplasty group at all time points (P > 0.05). CDVA didn't change along the observation period of three years in each of both groups (P > 0.05). CONCLUSIONS: Despite its suprachoroidal localization, the present study indicates that the miniaturized EYEMATE-SC IOP sensor doesn't negatively affect the long-term astigmatism after combined implantation with NPGS.

Assessment of choroidal thickness and volume during the water drinking test by swept-source optical coherence tomography.

OBJECTIVE: To evaluate changes in peripapillary and macular choroidal thickness and volume after the water-drinking test (WDT) using swept-source optical coherence tomography (SS OCT). DESIGN: Prospective, cross-sectional, observational study. PARTICIPANTS: Fifty-six eyes of 28 healthy volunteers. METHODS: Participants underwent a 3-dimensional optic disc and macula scanning protocol with a prototype SS OCT (Topcon, Inc., Tokyo, Japan) at baseline and 15, 30, 45, and 120 minutes after the start of the WDT. The WDT consisted of drinking 1000 ml of water within 5 minutes. Objective measurements of the choroid were obtained with automated segmentation of the choroidal boundaries. MAIN OUTCOME MEASURES: Choroidal thickness and volume. RESULTS: Mean age ± standard deviation of participants was 35.6 ± 9.1 years. Intraocular pressure (IOP) increased from 14.9 ± 2.7 mmHg at baseline to a peak of 16.8 ± 3.0 mmHg 15 minutes after the WDT (P < 0.001). Mean baseline choroidal thickness and volume were 181.3 ± 50.8 µm and 6.19 ± 1.80 mm(3), respectively, at the optic disc and 217.4 ± 43.6 µm and 7.83 ± 1.55 mm(3), respectively, at the macula. After the WDT, peripapillary and macular choroidal thickness increased by a maximum of 5.7% (P<0.001) and 4.3% (P<0.001), respectively. Choroidal volumes increased by 6.4% (P<0.001) and 3.9% (P<0.001), respectively. There was no association between change in IOP and peripapillary (P = 0.27) or macular (P = 0.09) choroidal thickness. CONCLUSIONS: Using automated segmentation of SS OCT measurements, significant increases in choroidal thickness and volume are observed after the WDT in healthy subjects.

Global rates of glaucoma surgery.

PURPOSE: To estimate global rates of glaucoma surgery. METHODS: National glaucoma and national ophthalmology societies were contacted to obtain rates of glaucoma surgery for the preceding 5 years. In countries without a professional society, leading ophthalmologists or non-governmental organizations (NGO) were approached. When available, published literature was used for the estimates. Three levels of evidence were assigned: published data from central government or insurance registries (level I), estimates provided by a national professional society based on survey of members (level II), and estimates based on data from individual glaucoma surgeons (level III). Glaucoma surgical rate (GSR) was defined as the annual number of total glaucoma surgeries performed per million population. Linear regression analysis was performed between GSR and the following parameters: population per ophthalmologist, per capita gross domestic product (GDP), and per capita health expenditures. RESULTS: Seventy-three glaucoma societies, 35 ophthalmology societies, as well as six NGOs and 37 leading ophthalmologists (11 other countries) were contacted. Data were obtained from 38 countries (10 level I, 23 level II, and 5 lev el III) with a total population of 1.723 billion. The average GSR was 139.2 ± 113.1 (range, 2.9-500.0). There was a positive correlation between GSR and GDP (r(2) = 0.309, P = 0.0004) and GSR and the number of ophthalmologists (r(2) = 0.476, P < 0.0001). CONCLUSION: There is a paucity of data on rates of glaucoma surgery, particularly from developing countries. The new metric GSR may be useful for the allocation of healthcare resources, as well as for planning and monitoring public health interventions in glaucoma.

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.

Effect of eyelid muscle action and rubbing on telemetrically obtained intraocular pressure in patients with glaucoma with an IOP sensor implant.

BACKGROUND: Patients with glaucoma on topical glaucoma medication are often affected by dry eye symptoms and thus likely to rub or squeeze their eyelids. Here, we telemetrically measure peak intraocular pressure (IOP) during eyelid manoeuvres and eyelid rubbing. METHODS: Eleven patients with primary open-angle glaucoma (POAG) previously implanted with a telemetric IOP sensor (Eyemate-IO) were instructed to look straight ahead for 1 min as a baseline measurement. Next, 6 repeats of blinking on instruction with 10 s intervals in between were performed. In addition, 5 repeats of eyelid closure (n=9), eyelid squeezing and eyelid rubbing (n=7) were performed with 15 s intervals in between. IOP was recorded via an external antenna placed around the study eye. Average peak IOP increases from baseline were analysed and tested against zero (no change) with one-sample t-tests. RESULTS: For eyelid rubbing, the average peak ∆ IOP increase (mean±SEM) was 59.1±9.6 mm Hg (p<0.001) from baseline. It was 42.2±5.8 mm Hg (p<0.0001) for eyelid squeezing, 3.8±0.6 mm Hg (n=9, p<0.01) for eyelid closure and 11.6±2.4 mm Hg (p<0.001) for voluntary blinking. No IOP change except for a short irregularity in the ocular pulse was observed during involuntary blinking. CONCLUSION: Eyelid manoeuvres in patients with POAG elicited brief increases in IOP that were particularly large with squeezing and rubbing. Further investigation of the potential implications for glaucoma progression is warranted.

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.

Surgical outcomes of excisional goniotomy using the kahook dual blade in severe and refractory glaucoma: 12-month results.

OBJECTIVES: To describe the efficacy and safety of goniotomy with trabecular meshwork excision using the Kahook Dual Blade (KDB, New World Medical Inc., Rancho Cucamonga, CA) in patients with severe or refractory glaucoma. METHODS: This retrospective multicentre case series reports on 40 eyes with severe or refractory open-angle glaucoma that underwent standalone or combined KDB goniotomy and were followed for 12 months post-operatively in the United-States, Mexico and Switzerland. Surgical success was defined as an intraocular pressure (IOP) reduction ≥20% from baseline at 12 months, with fewer medications than preoperatively. Mean IOP and antiglaucoma medication reduction, probabilities of achieving an IOP ≤16 or 18 mmHg, and adverse events were also analysed. RESULTS: Mean IOP decreased from 18.1 ± 5.0 mmHg at baseline to 14.8 ± 3.7 mmHg at 12 months (18.2% reduction, P < 0.001). Concomitantly, the mean number of glaucoma medications decreased from 2.5 ± 1.4 to 1.7 ± 1.2 (32% reduction, P = 0.002). The proportion of eyes achieving an IOP reduction of more than 20% from baseline was 37.5% (n = 15) at 12 months. At 12 months, 67.5% and 82.5% achieved a medicated IOP ≤ 16 and ≤18 mmHg, respectively. No severe complications were reported. CONCLUSION: Excisional goniotomy with KDB achieves a statistically significant IOP and antiglaucoma medication reduction in severe or refractory glaucoma over a period of 12 months. While its efficacy decreases with time, its favourable safety profile makes it a potentially useful primary or adjunctive procedure in high-risk eyes.