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.

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.

Visual Performance, Subjective Satisfaction and Quality of Life Effect of a New Refractive Intraocular Lens with Central Extended Depth of Focus.

PURPOSE: To assess the visual performance, clinical and quality of life outcomes, and subjective patient satisfaction after implantation of a new refractive/extended depth of focus (EDOF) hybrid intraocular lens (IOL). METHODS: This is a monocentric, retrospective study of 29 patients (45 eyes), carried out in a tertiary care glaucoma research centre. All patients underwent implantation of a Lucidis (Swiss Advanced Vision, SAV-IOL SA, Neuchâtel, Switzerland) IOL during cataract surgery. Near, intermediate, and distance best-corrected visual acuities and uncorrected visual acuities were collected at baseline and 3 months postoperatively. Adverse events, contrast sensitivity, optical aberrations, subjective satisfaction, and spectacle independence were also analysed at 3 months. RESULTS: At 3 months postoperatively, the mean photopic uncorrected monocular distance, and intermediate and near visual acuities were 0.2 logMAR (~ 20/32), 0.07 logMAR (~ 20/23), and 0.15 logMAR (~ 20/28), respectively. Mean best-corrected visual acuity was 0.05 logMAR (~ 20/23) for distance and 0.03 logMAR (~ 20/21) for near vision. Mean photopic contrast sensitivity was 1.5 log. The mean root mean square (RMS) was 0.119 ± 0.05 µm. Subjectively, over the 3-month follow-up, 9% of patients (n = 4) complained of halos, and 2% (n = 1) of photophobia. No other adverse events were noted. CONCLUSIONS: The Lucidis IOL demonstrates a good safety profile, with an acceptably low complication rate. While the uncorrected visual performance of this new optical design is inferior to that of other EDOF IOLs for distance vision, it achieves better results in intermediate and near vision, with consistently near-normal contrast sensitivity. Interestingly, self-reported spectacle independence and subjective patient satisfaction were high for all distances.

Efficacy and Safety of an Adjustable Glaucoma Drainage Device (eyeWatch System) for Refractory Glaucoma: A 2-Year Prospective Study.

PRCIS: In this study, we report a 2-year follow-up after implantation of an adjustable glaucoma drainage device combined with a novel orbital filtering plate. The IOP was efficiently controlled postoperatively with limited complications and an excellent safety profile. PURPOSE: To report the clinical results at 2 years after implantation of an eyeWatch (eW) system, which comprises an adjustable glaucoma drainage device (eW implant) combined with a novel orbital filtering plate (eyePlate), in refractory glaucoma. PATIENTS AND METHODS: Monocentric, prospective, noncomparative clinical trial. Patients suffering from refractory glaucoma after several failed surgeries were operated using the eW system. The primary outcome was the success rate, defined as an IOP ≤18 mm Hg and reduction of more than 20% from baseline, IOP ≥6 mm Hg. Secondary outcomes were mean IOP, visual acuity, the number of antiglaucoma medications, and the number and type of complications. RESULTS: Forty-two eyes from 42 patients were included. The mean follow-up time was 22.0±4.0 months. The mean baseline IOP decreased from 23.2±7.2 mm Hg before surgery to 11.9±4.4 mm Hg at 12 months ( P <0.001) and 11.5±3.0 at 24 months. The mean number of glaucoma medications decreased from 2.9±0.9 before surgery to 0.7±0.9 at 12 months ( P <0.001) and 1.0±0.9 at 24 months. The qualified success rate was 93% at 12 months and 90% at 24 months whereas the complete success rate was 46% and 40% at 12 and 24 months, respectively. Complications occurred in 7 patients. CONCLUSIONS: Implantation of the eW system effectively lowered IOP and reduced glaucoma medications for a 2-year period in patients who had previously failed glaucoma surgery. Persistent hypotony was not observed and the number of complications was low.

Outcomes of Nonpenetrating Versus Penetrating Deep Sclerectomy in Open Angle Glaucoma.

PRCIS: In this retrospective study, nonpenetrating deep sclerectomy (NPDS) and penetrating deep sclerectomy (PDS) interventions showed similar >90% complete success rates at 1-year postsurgery. However, NPDS achieved a superior safety profile in terms of best-corrected visual acuity (BCVA) recovery and rates of post-surgical complications. OBJECTIVE: Comparing the surgical outcomes of 2 surgical techniques: NPDS and PDS. PATIENTS AND METHODS: This was a retrospective, longitudinal, comparative study including 66 eyes from 57 patients aged 69 ± 9 years who underwent either NPDS or PDS for medically uncontrolled open angle glaucoma. Outcome measurements included intraocular pressure (IOP), BCVA, rates of complications, postoperative corrective interventions, and glaucoma medications at baseline and at all postoperative appointments up to 1 year. An exploratory mixed-effect model was used to assess the intergroup differences between IOP and BCVA. RESULTS: One-year postsurgery, a similar significant IOP reduction from baseline was observed in NPDS (from 19.9 ± 1.3 to 11.5 ± 0.9 mm Hg, P < 0.001) and PDS (from 19.5 ± 1.1 to 10.7 ± 0.6 mm Hg, P < 0.001). A conservative complete success rate (defined as medicated IOP ≤16 mm Hg and ≥20% reduction in IOP) was 87% for NPDS and 97% for PDS. No BCVA changes were observed between baseline and 1-year postsurgery in both groups, and glaucoma medications showed a similar 10-fold reduction in both groups ( P < 0.001 vs baseline). However, a significant difference in the speed of postoperative BVCA recovery was observed between NPDS and PDS ( P < 0.01), with NPDS showing a faster recovery. Moreover, lower numbers of postsurgical complications and postoperative interventions were observed after NPDS compared with PDS [NPDS, n = 30 and 34 vs PDS, n = 80 and 48 ( P < 0.05), respectively]. CONCLUSIONS: The present study confirmed that both NPDS and PDS are highly effective surgical interventions for the management of primary open angle glaucoma. However, NPDS had a superior safety profile in terms of BCVA recovery, complication rates, and postoperative interventions.

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.

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.

MRI after successful eyeWatchTM implantation.

The eyeWatchTM is a new glaucoma drainage device that includes an adjustable mechanism that can vary the resistance to aqueous humor outflow during the postoperative period to reduce the burden of postoperative intraocular pressure (IOP) management. The mechanism contains a magnetic rotor that can be adjusted using an external magnetic control unit. Adjustments of the position of the rotor are performed mostly in the initial postoperative follow-up period in order to reach the target IOP. However, for some patients, it might be necessary to perform MRI for the sake of medical investigations. As the MRI is creating a strong magnetic field, this magnetic field is likely to interact with the adjustable rotor of the eyeWatchTM, resulting in modification of the IOP. We report the case of an 82-old female patient successfully operated with the implantation of an eyeWatchTM. The patient underwent a cerebral MRI for persistent headache. Shortly after the MRI procedure, the patient was checked at the eye clinic to assess the position of the rotor and to measure the IOP. The eyeWatchTM was readjusted to the former position set before undergoing the MRI. No complications were reported in the follow-up after MRI. This case demonstrates that MRI examinations can be safely performed after glaucoma surgery using an eyeWatchTM without compromising on the quality of the imaging or the stability of the IOP. This is a complication-free procedure that only requires checking the new position of the rotor and re-adjusting the implant, if necessary, to achieve the target IOP.

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.

Causes and Managements of Early-Onset Ocular Hypertension Following Pars Plana Vitrectomy with Silicone Oil for Retinal Detachment and Exploration of Trabeculectomy as a Viable Alternative Management: A Pilot Study.

INTRODUCTION: This study aims to study a relatively unexplored topic about the causes and managements of early-onset ocular hypertension (OHTN) following the pars plana vitrectomy with silicone oil (PPV with SO) procedure for retinal detachment. Additionally, to explore the outcome of trabeculectomy in managing such patients. MATERIALS AND METHODS: This is a retrospective exploratory pilot study. We studied 23 patients who underwent the procedure then subsequently developed ocular hypertension within a month of the procedure. The probable causes for their early-onset ocular hypertension were identified and addressed with medicine, peripheral iridotomy (PI), complete or partial silicone removal. Trabeculoplasty was done in irretractable causes. This study aimed to evaluate the causes of early onset ocular hypertension after pars plana vitrectomy with silicone oil and explore the outcome of different managements including trabeculectomy. RESULTS: Inflammation (n=11, 47.8%) was the most common cause of early-onset ocular hypertension. Other causes were overfilling/spilling of silicone oil in anterior chamber (n=5, 21.7%), pupillary block (n=4, 17.4%) and angle-recession glaucoma (n=2, 8.69%). Majority of the cases responded to intraocular pressure (IOP) lowering medications (n=11). Three eyes with persistently high intraocular pressure underwent trabeculectomy after which the intraocular pressure was controlled. CONCLUSION: Even though prior studies have reported that trabeculectomy does not address late-onset ocular hypertension, our study shows that the procedure might be helpful in early-onset ocular hypertension. This is probably because at the time of presentation for early-onset ocular hypertension, silicone has not emulsified, which will not be the case in late-onset ocular hypertension. If a large study also shows that trabeculectomy can correct early-onset ocular hypertension, this information can guide the practices of ophthalmologists whose patients cannot afford expensive glaucoma drainage devices.

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.

In vivo study comparing an X-shaped polymethylmethacrylate and a cylindrical collagen implant for deep sclerectomy.

BACKGROUND: Study in vivo characteristics of a polymethylmethacrylate (PMMA) implant compared to the standard cylindrical collagen implant for deep sclerectomy (DS). DESIGN: Six-month comparative study. SAMPLES: Twenty eyes of ten rabbits. METHODS: Eyes were randomized to have DS with PMMA implant in one eye and collagen implant in the opposite eye. The growth of the new subconjunctival drainage vessels was assessed by combined fluorescein and indocyanin green anterior segment angiography; intrascleral and subconjunctival blebs were imaged by ultrasound biomicroscopy (UBM). At six months, outflow facility (C) was measured by anterior chamber perfusion and portions of one side of the DS were compared to portions on the 180° opposite side and native sclera on histology. RESULTS: The mean IOP preoperatively and at one, four, twelve, and twenty-four weeks was comparable in both groups (P > 0.1). UBM showed a statistically insignificant quicker regression of the subconjunctival bleb as well as a durable intrascleral lake in the PMMA group (P > 0.05). New drainage vessels were initially observed one month after surgery; they were more numerous in the PMMA group on angiographic and histological findings at 6 months (P < 0.05). The mean C increased significantly after surgery compared to preoperative values (P < 0.05) and no difference was observed between the implants (0.24 ± 0.06 µl/min/mmHg [PMMA] and 0.23 ± 0.07 µl/min/mmHg [collagen implant]) (P = 0.39). CONCLUSIONS: Deep sclerectomy performed with PMMA or collagen implants showed similar IOP lowering effects, outflow facility increase, and degree of inflammatory reaction.

Surgical Management of Pseudoexfoliative Glaucoma: A Review of Current Clinical Considerations and Surgical Outcomes.

INTRODUCTION: Pseudoexfoliative glaucoma (PEXG) is the most common cause of secondary open-angle glaucoma worldwide. It is more aggressive and often more resistant to conventional treatments than primary open-angle glaucoma, yet there is currently no clear consensus on best management practices. This review explores current literature on PEXG to assess the safety and efficacy of currently available surgical techniques, and discusses clinical considerations on the diagnosis and management of the disease. METHODS: A PubMed and Google Scholar search identified 2271 articles. These were reviewed to exclude irrelevant or duplicate data. A total of 47 studies reporting specifically on PEXG were retained and analyzed. REVIEW: One of the most significant ophthalmic consequences of pseudoexfoliative (PEX) syndrome is the compromising of the blood-aqueous barrier resulting in the leakage of inflammatory cytokines and extracellular matrix material into the anterior chamber. Considering the high risk of developing PEXG and the aggressive nature of this type of glaucoma, accurate and timely diagnosis of PEX is critical. Therefore, systematic attentive examination for PEX deposits is crucial. Patients diagnosed with PEX need frequent glaucoma assessments. Patient information is key to improving compliance. Gonioscopy and diurnal tension curves or 24-hour intraocular pressure (IOP) monitoring are integral part of the diagnostic work-up and risk-assessment of PEXG. Because of the lability of IOP in PEX, clinical decisions on the basis of single IOP measurements should be avoided. Cataract extraction was shown to provide persistent IOP-lowering effect in the order of 10% in PEXG. A number of other surgical options may offer wider IOP reduction, and both XEN 45 gel stents and angle-based glaucoma procedures were suggested to achieve better outcomes in PEXG than in primary open-angle glaucoma. Yet, more significant IOP reductions may be achieved with filtering surgery or glaucoma drainage device. Same day postoperative IOP monitoring is recommended to treat the frequent IOP spikes following surgery, and more aggressive anti-inflammatory therapy may reduce the rates of postoperative adverse events in PEXG. CONCLUSION: Specific studies of the surgical management of PEXG remain scarce in the medical literature, and more long-term and comparative studies are warranted to define more robust recommendations.

Combined and stand-alone XEN 45 gel stent implantation: 3-year outcomes and success predictors.

PURPOSE: To evaluate the 3-year treatment outcomes of XEN 45 gel stent in open-angle glaucoma patients. METHODS: In this prospective, single-centre interventional study, consecutive eyes with uncontrolled intraocular pressure (IOP) or signs of disease progression despite medical treatment underwent XEN implantation either alone or combined with phacoemulsification (Phaco + XEN). MAIN OUTCOME MEASURES: Surgical success was defined as 'complete' when 36-month unmedicated IOP was ≤15 mmHg with a relative IOP reduction ≥ 20% from medicated baseline, while the definition of qualified success allowed no more medications than at baseline. Other definitions of success with different IOP thresholds were also analysed. Secondary outcomes included mean IOP reduction, changes in ocular hypotensive medications and rates of reoperations. RESULTS: Out of 149 eyes initially included, 92 eyes (61.7%) of 68 patients had complete 3-year data (XEN: n = 26; Phaco + XEN: n = 66) after 38.2% were lost to follow-up. Mean age was 76.3 ± 9.1 years, and 66.2% were female. Mean medicated IOP decreased from 20.8 ± 7.4 mmHg (21.0 ± 7.4 [XEN] vs. 20.0 ± 6.9 mmHg [Phaco + XEN]) at baseline to 13.1 ± 3.4 mmHg (12.9 ± 2.9 [XEN] vs. 12.9 ± 3.4 [Phaco + XEN]) at 3 years (-37.0%; p < 0.001). Medications decreased from 1.9 ± 1.3 (2.4 ± 1.5 [XEN] vs. 1.9 ± 1.2 [Phaco + XEN]) to 0.4 ± 0.9 (0.3 ± 0.8 [XEN] vs. 0.5 ± 0.9 [Phaco + XEN]) (-78.9%; p < 0.001). Complete success and qualified success were achieved in 29.0% and 31.0% of eyes, respectively. Needling revision was performed in 51 eyes (55.4%), and 26.1% underwent reoperations. Risk factors for surgical failure included male gender (odds ratio [OR]:3.6; p = 0.03), diagnosis of POAG (OR: 4.5; p < 0.01) and undergoing needling revision (OR: 4.6; p < 0.01). While the type of procedure had no effect on the outcomes of PEXG, POAG eyes undergoing combined surgery had significantly higher rates of failure (OR: 7.29; p = 0.023). Most patients stable at 12-month remained so through to 3 years. CONCLUSIONS: At 3 years, XEN gel stent implantation achieved clinically significant IOP and medication reduction despite relatively high rates of needling and reoperations. Identifying patients at risk preoperatively may help optimize surgical outcomes.

Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma.

The efficacy and safety of a newly designed Ex-PRESS X-200 drainage device for the surgical treatment of glaucoma was evaluated. A clinical, prospective, monocentric, non-randomised, unmasked study on patients with medically uncontrolled glaucoma was performed. A superficial scleral flap was created. A posterior deep sclerectomy (DS) was dissected without opening the Schlemm's canal and an Ex-PRESS X-200 device was inserted under the scleral flap into the anterior chamber to drain aqueous humour into the intrascleral space. Biomicroscopy, best-corrected visual acuity (BCVA), applanation intra-ocular pressure (IOP) measurements, and fundus examination were performed before surgery, on the first day, the first week, and 1, 2, 3, 6, 12 and 18 months after surgery. The mean follow-up was 18.6 ± 2.4 months (mean ± SD) for the 26 eyes that were treated with the Ex-PRESS X-200 device. Pre-operatively, the mean BCVA was 0.6 ± 0.3, the mean IOP was 22.0 ± 5.1 mmHg, and the mean number of medications per patients was 2.8 ± 0.8. Eighteen months after surgery the mean BCVA was 0.5 ± 0.4, the mean IOP was reduced to 12.0 ± 3.9 mmHg, and the mean number of medications per patient was 0.6 ± 1.2. Eighty-five percent of patients achieved an IOP < 18 mmHg with or without medication and 69% without medication. Post-operative complications were hyphaema (15%), Seidel (15%), encysted blebs (54%) and bleb fibrosis in 8% of patients. Mitomycin C(MMC) was administered to 15 patients (58%) with needling being performed on 10 (38%) of these patients. Mid-term results of DS with the Ex-PRESS X-200 implant demonstrated its efficacy in controlling IOP with few post-operative complications in difficult eyes with an increased risk of surgery failure.

Outcome and Complications of Combined Modified Deep Sclerectomy and Trabeculectomy for Surgical Management of Glaucoma: A Pilot Study.

PURPOSE: To report the outcome and complications of a combined surgical technique of modified deep sclerectomy and trabeculectomy (mDST) for glaucoma. PATIENTS AND METHODS: Retrospective study of 44 eyes of 43 patients with open and closed angle glaucoma who underwent mDST. Outcome measures were: Surgical Success with 3 criteria - (i) criterion 1 = intraocular pressure (IOP) ≤21 mmHg or reduced by ≥20% of pre-operative IOP or IOP ≥6 mmHg on 2 consecutive time points after 3 months; (ii) criterion 2 = IOP ≤18 mmHg or reduced by ≥30% of pre-operative IOP or IOP ≥6 mmHg on 2 consecutive time points after 3 months and (iii) criterion 3 = IOP ≤15 mmHg or reduced by ≥40% of pre-operative IOP or IOP ≥6 mmHg on 2 consecutive time points after 3 months; IOP Reduction; Use of Anti-glaucoma Medication; Complications; Visual Acuity and Postoperative Interventions. RESULTS: Median follow-up was 40 months (range 24-77 months). At the final follow-up visit, the mean postoperative IOP was 11.5 ± 4.7 mmHg (p<0.0001). Mean number of anti-glaucoma medications decreased from 2.45 ± 1.21 to 0.54 ± 0.95 (p<0.0001). Surgical success in terms of IOP reduction was 50%; 43.2%; 36.4% for the 3 criteria respectively (complete success) and 70.5%; 56.8%; 47.7% for the 3 criteria respectively (qualified success). The complications noted were shallow/flat anterior chamber in 2 (4.54%), hyphema & bleb leak in 3 (6.81%), aqueous misdirection in 1 (2.27%), hypotonic maculopathy in 2 (4.45%) and hypotony requiring intervention in 6 (13.63%) eyes. CONCLUSION: Combined mDST was found to be an effective surgical procedure in reducing IOP. It was associated with complications commonly encountered in glaucoma filtering surgery. The use of intra-scleral space maintainer may help lower the risk of flat or shallow anterior chamber during the early postoperative period.

Efficacy of Needling Revision After XEN Gel Stent Implantation: A Prospective Study.

INTRODUCTION: The XEN gel stent is currently the only minimally invasive glaucoma surgical device that targets the subconjunctival outflow pathway through an ab interno placement. It has demonstrated a significant intraocular pressure (IOP)-lowering potential and a favorable safety profile compared with traditional filtering surgery. However, despite a less invasive approach, the presence of a filtering bleb inevitably implies some risk of complications. The most commonly reported bleb-related complication, with rates as high as 45%, is bleb fibrosis associated with raised IOP. To restore filtration in those failing blebs, needling revision is considered the procedure of choice. In this study, we present the results of mitomycin C-augmented needling after XEN implantation. METHODS: This was a prospective, interventional study, conducted at a single tertiary glaucoma center. Fifty-one eyes of 51 patients with raised IOP associated with either a fibrotic or shallow bleb or increased vascularity following XEN gel stent implantation at the investigation site between January 2015 and June 2016 were enrolled in this study. Patients with other identified causes of filtration failure (stent malposition, internal ostium obstruction, retained viscoelastic) were excluded. Included patients who underwent mitomycin C-augmented needling revision, and follow-up examinations were conducted at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. The primary outcome was the magnitude of IOP reduction following needling revision at the last follow-up visit. Secondary outcome measures were the number of needling procedures carried out in all patients, the rate of patients requiring further filtering surgery following needling revision, and the rate of intraoperative and postoperative complications associated with needling revisions. RESULTS: The average age was 74.4±9.6 years; 66.7% (n=34) were female individuals. Primary open-angle glaucoma was the most common diagnosis (n=21, 41.2%). A total of 78 needling procedures were performed over the 24-month follow-up. Overall 20 of 51 eyes (39.2%) required >1 needling revision, and 14 eyes (24.5%) eventually required reoperation to maintain IOP within their desired target range. Before XEN implantation, mean preoperative IOP was 22.3±8.2 mm Hg and decreased to 14.1±8.0 mm Hg at day 1 postoperatively (-36.8%). The last measured IOP before the first needling revision was on average 23.6±8.9 mm Hg, which reduced to a mean 12.1±4.2 mm Hg at the first postrevision appointment (-48.7%). At the last follow-up appointment, on average 17.0±7.0 months after the first needling, the mean IOP was 14.3±4.1 mm Hg (-35.9% and -39.4% from preoperative and prerevision baselines, respectively). Complications associated with needling revisions were partial amputation of the XEN implant during needling (n=2, 3.9%), hypotony with choroidal detachment (n=1, 2%), and failure to achieve target IOP requiring subsequent surgery (n=14, 27.5%). No association was found between any of the recorded characteristics and the number of needling revisions performed or their outcomes. DISCUSSION: The present study shows that needling revision following XEN gel stent implantation is a relatively safe and efficient intervention to restore filtration in failing blebs, with a significant and durable IOP-reduction potential.