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.

Outcomes of Non-Penetrating versus Penetrating Deep Sclerectomy in Open-Angle Glaucoma.

PRCIS: In this retrospective study, Non-Penetrating-Deep-Sclerectomy and Penetrating-Deep-Sclerectomy interventions showed similar >90% complete success rates at one-year post-surgery. However, Non-Penetrating-Deep-Sclerectomy achieved a superior safety profile in terms of best-corrected visual acuity recovery and rates of post-surgical complications. PURPOSE: Comparing the surgical outcomes of two surgical techniques: non-penetrating deep sclerectomy (NPDS) and penetrating deep sclerectomy (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), best-corrected visual acuity (BCVA), rates of complications, post-operative corrective interventions and glaucoma medications at baseline and at all post-operative appointments up to 1 year. An exploratory mixed-effects model was used to assess the intergroup differences for IOP and BCVA. RESULTS: One-year post-surgery, similar significant IOP reduction from baseline were observed in NPDS (from 19,9±1.3 to 11.5±0.9 mmHg, P<0.001) and PDS (from 19,5±1,1 to 10.7±0.6 mmHg, P<0.001). A conservative complete success rate (defined as medicated IOP ≤16 mmHg and ≥20% reduction in IOP) was of 87% for NPDS and 97% for PDS. No BCVA changes were observed between baseline and 1-year post-surgery 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 post-operative BVCA recovery was observed between NPDS and PDS (P<0.01), NPDS showing a faster recovery. Moreover, lower numbers of post-surgical complication and post-operative interventions were observed following NPDS compared to 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 post-operative interventions.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Iridocorneal Angle Assessment After Laser Iridotomy With Swept-source Optical Coherence Tomography.

AIM: To investigate the reliability of anterior chamber angle (ACA) measurements in narrow angles and assess the effect of laser peripheral iridotomy (LPI) on these measurements using novel swept-source optical coherence tomography (SS-OCT) technology. MATERIALS AND METHODS: In this prospective observational study, patients with gonioscopically narrow angles were enrolled and scheduled for prophylactic LPI. Twelve ACA sections were obtained in each eye using SS-OCT (ANTERION, Heidelberg Engineering, Germany) before and after Nd:YAG LPI. A built-in algorithm calculated ACA measurements after manual identification of the scleral spur and ACA recess. Eight ACA parameters were evaluated: ACA (ACA 500, ACA 750); scleral spur angle (SSA 500, SSA 750); angle opening distance (AOD 500, AOD 750); and trabecular iris space area (TISA 500, TISA 750). The effect of LPI was assessed for each parameter, both nasally and temporally. RESULTS: Ten patients (18 eyes) were enrolled (mean age, 61.8±13.6 y; 60.0% female individuals). On average, the ACA was wider nasally than temporally (P=0.004). LPI significantly widened the ACA (range, 26.7-29.4%; P<0.05). ACA 500 increased by 29.4% (P<0.001), ACA 750 by 29.2% (P=0.002), SSA 500 by 27.3% (P=0.003), SSA 750 by 28.1% (P=0.001), AOD 500 by 28.6% (P=0.009), AOD 750 by 28.6% (P=0.003), TISA 500 by 27.3% (P=0.004), and TISA 750 by 26.7% (P=0.200). CONCLUSIONS: SS-OCT ANTERION imaging can be used to reliably measure ACA before and after LPI. ACA, AOD, SSA, and TISA are all valid ACA measurement methods.

A Prospective Analysis of iStent Inject Microstent Implantation: Surgical Outcomes, Endothelial Cell Density, and Device Position at 12 Months.

PRECIS: The surgical outcome of iStent inject devices is associated with device protrusion within the anterior chamber. Schlemm canal (SC) dilatation has a prognostic value. iStent inject devices do not move within the first year after implantation. INTRODUCTION: The iStent inject is a device designed to be implanted ab-interno through the trabecular meshwork. The present study follows up on our preliminary report, using successive in vivo anterior segment optical coherence tomography (AS-OCT) imaging to analyze the associations between stent positioning, iridocorneal angle structures, and surgical outcomes. METHODS: In total, 54 eyes of 42 patients (73.3±7.4 y) with cataract and mild-to-moderate open-angle glaucoma were examined in this prospective study. All patients underwent implantation of 2 iStent inject devices combined with phacoemulsification. Patients were followed up over a 12-month period. AS-OCT was performed after 3 and 12 months. Thirty unoperated fellow eyes served as control eyes. RESULTS: Intraocular pressure (IOP) decreased from 16.5±4.2 mm Hg at baseline to 15.1±3.7 mm Hg at 12 months (-8.7%; P=0.004), while medications decreased from 1.8±1.0 to 0.5±0.9 (-72.2%; P<0.001). Unmedicated IOP≤18 mm Hg was achieved in 58.8% of operated eyes. No sight-threatening complications were reported. On AS-OCT, 44.9% of devices were buried within the trabeculum. Device position was unchanged between scans. Regression analysis elicited significant predictors: SC dilatation effect [risk ratio (RR)=0.230; P=0.003], greatest SC diameter (RR=0.991; P=0.049), extrusion of the most anterior device (RR=0.993; P=0.012), gonioscopically visible devices (RR=0.406; P=0.040), baseline treatments (RR=2.214; P=0.001), and baseline IOP (RR=0.184; P=0.006). Endothelial cell density decreased by 14.6% at 12 months (P<0.001). CONCLUSIONS: This study demonstrates the IOP-lowering and medication-lowering potential of iStent inject surgery in primary open-angle and pseudoexfoliative glaucoma. It confirms that surgical outcomes are positively associated with device protrusion within the anterior chamber, and suggests SC dilatation effect as a favorable prognostic indicator. It shows that stents are stable in time, highlighting the importance of the initial implantation location.

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.

Bilateral XEN Stent Implantation: A Long-term Prospective Study of the Difference in Outcomes Between First-operated and Fellow Eyes.

BACKGROUND/AIMS: Both eyes of a same person are not completely independent entities. The purpose of this study was to assess the difference in outcome between the first-operated eye and the fellow-operated eye following bilateral XEN surgery, and to identify potential success predictors for the fellow eye. METHODS: This single-site, prospective, nonrandomized interventional study investigated bilateral nonsimultaneous XEN gel stent implantation over 24 months. Its main outcome measure was surgical success, defined as unmedicated intraocular pressure (IOP) ≤15 mm Hg associated with a relative reduction ≥20%. RESULTS: Of 149 enrolled eyes, 74 eyes of 37 patients who underwent bilateral (standalone or combined) XEN implantation, within a mean of 50.5±74.3 days of each other, were analyzed. Postoperatively, mean medicated IOP decreased from 19.0±6.6 (first-operated) and 18.2±5.2 mm Hg (fellow) at baseline (P=0.209) to 13.7±4.0 (-27.9%; P<0.001; first-operated) and 14.1±3.6 mm Hg (-22.5%; P<0.001; fellow) after 2 years (P=0.673). Rates of complete success were comparable between first-operated and fellow eyes (P=0.65). At 2 years, among patients whose first-operated eyes were considered a failure, 92.0% of fellow eyes failed (P=0.001). The odd ratio of a fellow eye experiencing complete success were 16.1 (95% confidence interval: 2.5-101.9, P=0.003) if the first operated eye experienced complete success. CONCLUSIONS: The present study demonstrated a strong association between first-operated eyes and fellow eyes following XEN gel stent implantation, in terms of surgical outcomes and IOP reduction. In effect, surgical success in the first-operated eye increases the odds of success in the fellow eye by 16-folds.

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.