MERCURY-3: a randomized comparison of netarsudil/latanoprost and bimatoprost/timolol in open-angle glaucoma and ocular hypertension.

PURPOSE   : To compare the efficacy and safety of the fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (NET/LAT; Roclanda®) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®) ophthalmic solution in the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT). METHODS: MERCURY-3 was a 6-month prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, non-inferiority study. Patients (≥ 18 years) with a diagnosis of OAG or OHT in both eyes that was insufficiently controlled with topical medication (IOP ≥ 17 mmHg in ≥ 1 eye and < 28 mmHg in both eyes) were included. Following washout, patients were randomized to once-daily NET/LAT or BIM/TIM for up to 6 months; efficacy was assessed at Week 2, Week 4, and Month 3; safety was evaluated for 6 months. Comparison of NET/LAT relative to BIM/TIM for mean IOP at 08:00, 10:00, and 16:00 h was assessed at Week 2, Week 6, and Month 3. Non-inferiority of NET/LAT to BIM/TIM was defined as a difference of ≤ 1.5 mmHg at all nine time points through Month 3 and ≤ 1.0 mmHg at five or more of nine time points through Month 3. RESULTS: Overall, 430 patients were randomized (NET/LAT, n = 218; BIM/TIM, n = 212), and all received at least one dose of study medication. Efficacy analyses were performed at Month 3 on 388 patients (NET/LAT, n = 184; BIM/TIM, n = 204). NET/LAT demonstrated non-inferiority to BIM/TIM, with a between-treatment difference in IOP of ≤ 1.5 mmHg achieved at all time points and ≤ 1.0 mmHg at the majority of time points (six of nine) through Month 3. Mean diurnal IOP during the study ranged from 15.4 to 15.6 mmHg and 15.2 to 15.6 mmHg in the NET/LAT and BIM/TIM groups respectively, with no between-group statistically significant difference. No significant differences were observed in key secondary endpoints. No serious, treatment-related adverse events (AEs) were observed, and AEs were typically mild/moderate in severity. The most common treatment-related AEs were conjunctival hyperemia (NET/LAT, 30.7%; BIM/TIM, 9.0%) and cornea verticillata (NET/LAT, 11.0%; BIM/TIM, 0%). CONCLUSIONS: Once-daily NET/LAT was non-inferior to BIM/TIM in IOP reduction in OAG and OHT, with AEs consistent with previous findings. NET/LAT offers a compelling alternative FDC treatment option for OAG and OHT.

Effects of socioeconomic status on baseline values and outcomes at 24 months in the Treatment of Advanced Glaucoma Study randomised controlled Trial.

BACKGROUND/AIMS: Socioeconomic status (SES) is associated with late disease presentation and poorer outcomes. We evaluate the effect of SES on treatment outcomes and report the correlation between SES and baseline characteristics of participants in the Treatment of Advanced Glaucoma Study. METHODS: Pragmatic multicentre randomised controlled trial. Four hundred and fifty-three patients presenting with advanced open-angle glaucoma in at least one eye (Hodapp-Parrish-Anderson classification). Participants were randomised to either glaucoma drops (medical arm) or trabeculectomy (surgery arm). Clinical characteristics, Quality of life measurement (QoL) and SES defined by the Index of Multiple Deprivation are reported. Subgroup analysis explored treatment effect modifications of SES at 24 months. Correlation between SES and baseline characteristics was tested with the χ2 test of association for dichotomous variables and pairwise Pearson's correlation for continuous variables. RESULTS: The mean visual field mean deviation was -17.2 (6.7)dB for the most deprived quintile of participants and -13.0 (5.5) for the least deprived quintile in the index eye. At diagnosis, there was a strong correlation between SES and ethnicity, age, extent of visual field loss and number of visits to opticians prior to diagnosis. At 24 months, there was no evidence that the treatment effect was moderated by SES. CONCLUSIONS: In patients presenting with advanced glaucoma. SES at baseline is correlated with poorer visual function, poorer Visual Function Questionnaire-25 QoL, ethnicity, age and number visits to an optician in the years preceding diagnosis. SES at baseline does not have an effect of the success of treatment at 24 months. TRIAL REGISTRATION NUMBER: ISRCTN56878850.

Quantification of Postoperative Inflammation in Laser and Surgical Procedures for Glaucoma with Laser Flare Photometry: A Review of the Literature.

PURPOSE: To review the application of laser flare photometry (LFP) in the objective quantification of aqueous flare (anterior chamber inflammation) post laser and surgical procedures for glaucoma. METHODS: A search was undertaken using the following: PubMed (all years), the Web of Science (all years), Ovid MEDLINE (R) (1980 to 30 March 2023), Ovid MEDLINE (R) Daily Update 30 March 2023, MEDLINE and MEDLINE non-indexed items, Embase (1980-2021, week 52), Ovid MEDLINE (R) and Epub Ahead of Print, in-Process & Other Non-Indexed Citations and Daily (1980 to 30 March 2023), CENTRAL (including Cochrane Eyes and Vision Trials Register), metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrial.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (www.who.int/ictrp/search/en). Search terms included "aqueous flare," "anterior chamber inflammation," "tyndallometry," "laser flare photometry" combined with "laser," "iridotomy," "trabeculoplasty," "cataract surgery," "phacoemulsification," "glaucoma surgery," "minimally invasive glaucoma surgery," "trabeculectomy," "aqueous shunt," "glaucoma drainage" and "cyclophotocoagulation." RESULTS: The majority of studies utilizing laser flare photometry in grading flare have been post laser trabeculoplasty. The degree of flare produced varies according to the type of glaucoma laser or surgery performed, with filtration procedures and glaucoma drainage devices having marked and prolonged detectable levels. Aqueous flare in cyclodestructive procedures positively correlated with intraocular pressure (IOP) reduction. CONCLUSION: In comparison to clinician grading, laser flare photometry provides a more objective measure of post-surgical inflammation in eyes that have undergone laser and surgery for glaucoma. Further research is warranted into how this instrument can be utilized to identify eyes at high risk of failure and other adverse outcomes after glaucoma surgery.

Factors influencing aqueous flare after cataract surgery and its evaluation with laser flare photometry.

Despite the refinement of modern cataract surgery, postoperative inflammation still constitutes a substantial amount of visual morbidity worldwide. A surrogate for intraocular inflammation and blood-aqueous barrier breakdown can be objectively quantified by Laser flare photometry (LFP). This review outlines the utility of LFP in assessing the assessment of post-cataract surgery inflammation. It highlights the impact of preoperative pathological states such as uveitis and diabetes, intraoperative techniques, including efficient phacoemulsification and direct comparisons between postoperative anti-inflammatory regimes. There is a large interobserver variation in the subjective flare measurement after cataract surgery and the continued use of LFP amongst other objective, noninvasive measurements of intraocular inflammation, particularly in the further development of cataract surgery, is recommended.

Comparing the Effectiveness of Phacoemulsification + Endoscopic Cyclophotocoagulation Laser versus Phacoemulsification Alone for the Treatment of Primary Open Angle Glaucoma in Patients with Cataract (CONCEPT): Study Methodology.

OBJECTIVE: To describe the methodology of the Comparing the Effectiveness of Phacoemulsification + Endoscopic Cyclophotocoagulation Laser and Phacoemulsification Alone for the Treatment of Primary Open Angle Glaucoma in Patients with Cataract (CONCEPT) study, a randomized controlled trial. DESIGN: Double-masked, randomized controlled trial. SUBJECTS, PARTICIPANTS, AND/OR CONTROLS: Participants will be recruited from 5 United Kingdom-based centers. One hundred and sixty eyes with a diagnosis of primary open-angle glaucoma and visually significant cataract will be included. Eighty eyes will be randomized to undergo cataract surgery alone and eighty to undergo cataract surgery with endoscopic cyclophotocoagulation (ECP). METHODS: The baseline diurnal washout intraocular pressure (IOP) will be measured. The participants will be randomized to undergo cataract surgery alone or cataract surgery with ECP upon completion of uncomplicated cataract surgery. At the 1- and 2-year post surgery follow-up visits, the measurements of washout diurnal IOP will be repeated. MAIN OUTCOME MEASURES: Diurnal washout IOP, use of glaucoma medications, and adverse events. CONCLUSIONS: We described the methodology of the first randomized controlled trial comparing cataract surgery alone with cataract surgery combined with ECP in the context of patients with primary open-angle glaucoma and symptomatic cataract. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Double scleral tunnel technique to prevent glaucoma drainage device exposure.

PURPOSE: To describe a new surgical technique designed to reduce the risk of tube exposure following glaucoma drainage device (GDD) surgery. METHODS: A retrospective, single-center study included all patients who underwent GDD surgery by a single surgeon between January 2018 and December 2019, using a double scleral tunnel technique to secure the tube to the sclera. A 23-gauge needle was used to create a 3 mm partial thickness scleral tunnel near to the GDD plate, with a second partial thickness scleral tunnel created 2.5 mm from the surgical limbus into the anterior chamber (AC). The silicone tube was passed through both scleral tunnels and into the AC. RESULTS: 46 GDD surgeries were performed during the time frame. The mean age of patients was 65 ± 13 years. Mean follow up duration was 27.7 ± 8.15 months (range 11 to 44). Significant reductions in intraocular pressure and number of glaucoma medications were achieved. Zero exposures were recorded occurring during follow-up. CONCLUSION: This double scleral tunnel technique to secure the GDD silicone tubing firmly to the sclera may reduce micro-movements which have been purported to be associated with tissue erosion post GDD surgery. The addition of this simple technique to existing GDD surgery may reduce the risk of post-operative tube exposure.

Clinical Outcomes and Cost Analysis of PreserFlo versus Trabeculectomy for Glaucoma Management in the United Kingdom.

PURPOSE: Clinical evaluation and cost analysis of mitomycin-C-augmented PreserFlo MicroShunt versus trabeculectomy. DESIGN: Retrospective cohort study across 3 teaching hospitals. PARTICIPANTS: A total of 134 consecutive eyes of 129 patients (70 undergoing MicroShunt, 64 trabeculectomy). METHODS: Primary and secondary glaucoma cases with uncontrolled intraocular pressure (IOP) were included. Neovascular glaucoma and surgery combined with cataract extraction were excluded. The cost analysis used results from the clinical study to estimate operative costs (equipment and staff costs) and postoperative costs (follow-up visits, nonglaucoma medications, and postoperative procedures) per eye for PreserFlo and trabeculectomy. MAIN OUTCOME MEASURES: The primary clinical outcome measure was surgical failure (defined as IOP > 21 mmHg or < 20% reduction from baseline, IOP ≤ 5 mmHg, reoperation, or loss of light perception) or qualified and complete success (with or without medication) at 18 months. Secondary measures were IOP, glaucoma medications, visual acuity, mean deviation, time to cessation of steroid drops, complications, surgical time, follow-up visits, postoperative interventions, and reoperations. The cost analysis evaluated costs of PreserFlo compared with trabeculectomy. RESULTS: Baseline characteristics were similar, except for more non-White patients in the trabeculectomy group (51% Black and Asian vs. 32% MicroShunt, P = 0.02) and more cases with prior ab externo glaucoma surgery in the MicroShunt group (19% vs. 3% in the trabeculectomy group, P = 0.004). Overall, 59% of eyes had primary open-angle glaucoma. Mean follow-up was 19.9 months for both groups. At 18 months, surgical failure was 25% for MicroShunt compared with 35% for trabeculectomy (P = 0.18). Failure in MicroShunt cases was due to inadequate IOP reduction (84%) or reoperation for glaucoma (16%). Failure in trabeculectomy cases was due to inadequate IOP reduction (58%), persistent hypotony (29%), or reoperation for glaucoma (13%). Combined blebitis and endophthalmitis rate was 1.4% for MicroShunt and 3.1% for trabeculectomy. Cost analysis showed a savings of £245 to £566 per eye in the MicroShunt group, driven mostly by reduced postoperative procedures and follow-up visits. This is in contrast to prior randomized controlled trial data reporting the incremental cost of $2058 of PreserFlo over trabeculectomy. CONCLUSIONS: Our experience of introducing PreserFlo MicroShunt surgery showed it was safer than trabeculectomy and is a cost-saving and effective option that offers potential to free up highly limited National Health Service resources. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Postoperative Complications in the Primary Tube Versus Trabeculectomy Study During 5 Years of Follow-up.

PURPOSE: To describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group. METHODS: Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: Surgical complications, reoperations for complications, visual acuity, and cataract progression. RESULTS: Early postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77) CONCLUSIONS: A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.

Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 5 Years of Follow-up.

PURPOSE: To report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group. METHODS: Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, or loss of light perception. Secondary outcome measures included IOP, glaucoma medical therapy, and visual acuity. RESULTS: The cumulative probability of failure after 5 years of follow-up was 42% in the tube group and 35% in the trabeculectomy group (P = 0.21; hazard ratio = 1.31; 95% confidence interval = 0.86-2.01). At 5 years, IOP (mean ± standard deviation) was 13.4 ± 3.5 mmHg in the tube group and 13.0 ± 5.2 mmHg in the trabeculectomy group (P = 0.52), and the number of glaucoma medications (mean ± standard deviation) was 2.2 ± 1.3 in the tube group and 1.3 ± 1.4 in the trabeculectomy group (P < 0.001). CONCLUSIONS: Trabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy. No significant difference in the rate of surgical failure was observed between the 2 surgical procedures at 5 years.

Conjunctival erosion following a PRESERFLO® MicroShunt procedure.

PURPOSE: We describe a case of conjunctival erosion following a PRESERFLO® MicroShunt procedure, and the subsequent revision surgery. OBSERVATIONS: Conjunctival erosion was noted overlying the MicroShunt implant at postoperative week 11, 8 weeks following a bleb needling procedure for bleb encapsulation. A brisk leak was observed at the site of erosion. The patient underwent a subsequent revision procedure with repositioning of the MicroShunt implant and mitomycin C (MMC) application. CONCLUSION AND IMPORTANCE: Conjunctival erosion may be a relatively rare but important complication following MicroShunt surgery and may arise from a variety of risk factors. Extra care should be taken during bleb needling in the context of MicroShunt, and needling should be directed posteriorly, beyond the distal tip of the MicroShunt.

Long-term outcomes in Primary congenital glaucoma, aniridia and anterior segment dysgenesis.

AIM: To determine the long-term outcomes of a cohort of complex patients with primary congenital glaucoma, aniridia and anterior segment dysgenesis. METHODS: Retrospective consecutive series between 1990-2021 in two UK tertiary centres: Guy's and St Thomas' NHS Foundation Trust and King's College Hospital NHS Foundation Trust. We recorded the number and types of surgical and laser treatments along with preoperative and postoperative data, including intraocular pressures (IOP) and anti-glaucoma medications. RESULTS: A total of 41 eyes of 21 patients were included. Primary diagnoses were primary congenital glaucoma in 16 eyes (39.0%), aniridia in 14 eyes (34.2%), and anterior segment dysgenesis in 8 eyes (19.5%). Sixteen eyes (39.0%) had one or more glaucoma surgery or laser procedures for advanced glaucoma, and the long-term follow-up was 12.8 ± 3.6 years. There was a significant decrease in postoperative IOP (mmHg) at 3 months (16.5 ± 1.6; p = 0.0067), 6 months (18.7 ± 2.1; p = 0.0386), 12 months (18.6 ± 1.7; p = 0.0229), 3 years (14.7 ± 1.2; p = 0.0126), 5 years (15.5 ± 1.8; p = 0.0330) and 10 years (15.4 ± 2.3; p = 0.7780), compared to preoperatively (24.1 ± 2.6). Surgical success (complete and qualified) was 62.5%, 50.0%, 43.8%, 46.2%, 45.5% and 28.6% at 3 months, 6 months, 12 months, 3 years, 5 years and 10 years, respectively. There was no significant change in the number of anti-glaucoma drugs postoperatively (p > 0.05). Four eyes (25.0%) had postoperative complications (hyphaema, hypotony) that resolved after conservative management. CONCLUSIONS: Surgical management of these complex eyes with advanced glaucoma is challenging. Overall, the cohort had good surgical outcomes with a significant decrease in IOP by 36.1% after long-term follow-up.

Phacoemulsification combined with micropulse cyclodiode laser in glaucoma patients: efficacy and safety.

OBJECTIVE: To evaluate the safety and efficacy of phacoemulsification combined with Micropulse transscleral cyclophotocoagulation (MP-TSCPC) in glaucoma patients. METHODS: This is a retrospective case-note review. The participants were adult patients with diagnoses of glaucoma and cataract who required a further reduction in IOP or a reduction in the number of glaucoma drops. All consecutive patients who underwent cataract surgery (CS) combined with MP-TSCPC laser between October 2018 and July 2019 were included in the study. The effect on visual acuity (VA), intraocular pressure (IOP) and number of anti-glaucoma drops were evaluated at 6 and 12 months in addition to any complications that occurred during any time point of the study. RESULTS: 42 eyes were included in the study. Mean IOP was reduced from 19.5 ± 5.4 mmHg by 22.5% to 15.1 ± 4.6 at 6 months post-operatively and by 19.5% to 15 ± 6.6 mm Hg at 12 months (p < 0.001 at both time points). The number of anti-glaucoma medications also reduced significantly from 2.8 ± 1.3 to 1.6 ± 1.2 at 6 months and to 2.2 ± 1.3 at 12 months (p < 0.001 at both time points). The success rate was 56% at 6 months and 54% at 12 months. 54.7% of our patients who completed 12 months follow up had an improvement or unchanged vision at the last visits. CONCLUSION: This is the first study evaluating the effect of cataract surgery combined with MP-TSCPC in glaucoma patients. We demonstrated that this led to a reduction in IOP and the number of anti-glaucoma medications at 6 and 12-month postoperatively. The majority of patients had either stable or better vision at 12 months follow-up.

Intraocular pressure changes following topical ocular hypotensive medications washout.

BACKGROUND: To review the changes in intraocular pressure (IOP) following topical hypotensive medications washout in patients with primary open angle glaucoma (POAG), ocular hypertension (OHT) and uveitic glaucoma (UG)/OHT. METHODS: The study included 120 patients with POAG, OHT and UG recruited from prospective clinical trials between February 2013 and July 2017. We excluded 20 eyes with IOP of ≤21 mm Hg, 11 eyes with previous incisional surgery and 17 eyes with incomplete data. UG eyes with active inflammation and on steroid treatment were excluded. Participants underwent a 1-month washout period from topical ocular hypotensive medications before IOP phasing. Comparisons were made between pre/post-washout IOP, and highest-recorded (peak) and post-washout IOP. RESULTS: A total of 110 eyes with POAG, 33 eyes with OHT and 43 eyes with UG were included for analysis. The mean pre-washout IOP was 18.1±3.3 mm Hg in POAG, 18.8±3.3 mm Hg in OHT and 17.9±8.8 mm Hg in UG; the mean post-washout IOP was 26.6±4.8 mm Hg, 26.4±3.9 mm Hg, 23.1±10.1 mm Hg in POAG, OHT and UG, respectively. The mean increase in IOP after washout was significantly lower in UG compared with POAG and OHT eyes (p=0.01). The percentage of eyes with post-washout IOP <22 mm Hg was 12.7% in POAG, 6.1% in OHT and 51.2% in UG. CONCLUSION: Active inflammation and steroid treatment contributes to elevated IOP in uveitis. Therefore, IOP may revert to normal once inflammation subsides. We recommend ocular hypotensive treatment washout to be considered in UG eyes that have IOP under control in the absence of recurrence of uveitis.

Effect of high-intensity focused ultrasound (HiFU) treatment on intraocular pressure and aqueous humour dynamics: 12 -months results.

PURPOSE: High intensity focused ultrasound (HiFU) is a cyclodestructive therapy for controlling intraocular pressure (IOP) in glaucoma. The mechanism of action is thought to be through destruction of the ciliary epithelium as well as increased uveoscleral outflow. We reviewed the change in aqueous humour dynamics parameters including aqueous humour flow rate, tonographic outflow facility (TOF) and uveoscleral outflow at 12 months. PATIENTS AND METHODS: This is a prospective observational study. Consecutive patients with open angle glaucoma (OAG) or ocular hypertension (OHT) requiring further IOP lowering were enroled in the study between August 2016 and January 2017. Patients were commenced on medication washout period prior to baseline and twelve months' visit. RESULTS: Sixteen patients (OAG) in the treatment group underwent assessment at twelve months follow up. Mean age was 63.1 ± 11 years. Eleven patients were African/Caribbean and 5 were Caucasian. Nine patients were female and 7 were male. Mean post-washout IOP was reduced by 21% (28.3 ± 5.7 at baseline vs 22.4 ± 8.4 mmHg at 12 months, p = 0.04). Aqueous humour flow rate was reduced by 16% at twelve months (2.40 ± 0.6 at baseline vs 2.02 ± 0.6 µl/min at 12 months, p = 0.0493). There was no statistically significant change in the TOF (0.12 ± 0.09 at baseline vs 0.08 ± 0.05 µl/min/mmHg at 12 months, p = 0.08) or uveoscleral outflow (0.6 ± 1.3 at baseline vs 1.3 ± 0.85 µl/min at 12 months, p = 0.15). CONCLUSION: In this study, we demonstrated that the observed IOP reduction was likely due to aqueous humour flow rate reduction. The TOF and uveoscleral outflow were not detectibly changed.

Treatment Outcomes Using the PAUL Glaucoma Implant to Control Intraocular Pressure in Eyes with Refractory Glaucoma.

PURPOSE: To investigate efficacy 1 year after implantation of a novel glaucoma tube shunt, the PAUL Glaucoma Implant (PGI; Advanced Ophthalmic Innovations, Singapore, Republic of Singapore), in the treatment of eyes with refractory glaucoma. DESIGN: Clinical trial. PARTICIPANTS: Glaucoma patients who are recalcitrant to maximum tolerated medical therapy and require tube shunt surgery. METHODS: Interventional cohort study involving consecutive PGIs implanted at 6 international centers between December 1, 2017, and December 1, 2018. All the participants were followed up for 1 year after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was failure, defined prospectively as intraocular pressure (IOP) of more than 21 mmHg or less than 20% reduction from the preoperative baseline on 2 consecutive visits, 3 months or more after surgery; persistent late hypotony, defined as IOP of less than 6 mmHg on 2 consecutive visits after 3 months; additional glaucoma surgery; loss of light perception vision; or removal of the implant for any reason. RESULTS: Of 82 patients enrolled, 74 (74 eyes) completed 12 months of follow-up. The mean age ± standard deviation at enrollment was 62.3±14.7 years, 73.0% were men, and 36.5% had secondary glaucoma. One year after surgery, 4 patients (5.4%) fulfilled the surgical criteria for failure, 68.9% (51/74 eyes) were deemed complete successes, and 93.2% (69/74 eyes) were considered qualified successes. Compared with the medicated preoperative IOP (23.1±8.2 mmHg), the postoperative IOPs at 6 and 12 months were 13.8±4.0 mmHg and 13.2±3.3 mmHg, respectively (P < 0.001). The mean number of IOP-lowering drugs used before surgery and after 12 months of follow-up were 3.3±0.9 and 0.3±0.6, respectively (P < 0.001). Significant postoperative complications included self-limiting shallow anterior chamber (n = 11; 14.9%), hypotony requiring intervention (n = 7; 9.5%), tube shunt occlusion (n = 5; 6.8%), tube exposure (n = 3; 4.1%), and endophthalmitis with resultant loss of vision (n = 1; 1.4%). CONCLUSIONS: The PGI demonstrated comparable efficacy with other currently available implants, with almost three quarters of the enrolled patients with refractory glaucoma achieving complete surgical success after 1 year of follow-up.