To assess the effectiveness and safety of bimatoprost sustained release (SR) glaucoma implant as a treatment for open-angle glaucoma and ocular hypertension in a real-world private practice setting ...with a significant American Indian population.
This retrospective study included 156 eyes from adult patients who received a single injection of bimatoprost implant between June 2020 and May 2022 at the Oklahoma Eye Surgeons. Patients were stratified by baseline intraocular pressure (IOP) (≥21 mmHg versus IOP<21 mmHg). The co-primary endpoints were changes in the mean IOP and the number of topical IOP-lowering medications from baseline to Month 6.
At 6 months, eyes with baseline IOP≥21 mmHg had a significantly lower mean IOP (19.85±8.01 versus 26.25±4.84 mmHg; p<0.0001) and the mean number of IOP-lowering medications (1.04±1.44 versus 1.38±1.50; p=0.048) compared with baseline. One year after implantation, 73.58% of eyes had a ≥20% reduction in IOP, 41.51% were medication-free and 30.19% were receiving at least one fewer medication. Among eyes with baseline IOP<21 mmHg, there was a significant reduction in the mean number of IOP-lowering medicines by Month 6 (0.61±1.03 versus 1.93±1.21 at baseline; p<0.0001), with no change in IOP. At 12 months, 24.27% of eyes had a ≥20% decrease in IOP, 43.69% of eyes did not require any medications and 63.11% had at least one fewer medication compared with baseline. An analysis using Welch's two-sample
-test showed no significant differences in the outcomes between the overall population and the American Indian population (number of eyes, 23).
Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled baseline IOP. No clinically meaningful and statistically significant differences in the efficacy of bimatoprost were observed in patients of American Indian descent.
Purpose To compare the clinical outcomes of the EX-PRESS glaucoma filtration device placed under a partial-thickness scleral flap with trabeculectomy. Design Randomized, prospective, multicenter ...trial. Methods A total of 120 eyes in 120 subjects were analyzed, including 59 eyes treated with EX-PRESS and 61 eyes treated with trabeculectomy. Both the EX-PRESS and the trabeculectomy groups were treated intraoperatively with mitomycin C and followed postoperatively for 2 years. Surgical success was defined as 5 mm Hg ≤ intraocular pressure ≤ 18 mm Hg, with or without medications, without further glaucoma surgery. Results Mean intraocular pressure was significantly reduced compared with baseline in both groups ( P < 0.001). Average intraocular pressure and number of medications were similar in both groups during follow-up, with mean intraocular pressure at 2 years after surgery of 14.7 ± 4.6 mm Hg and 14.6 ± 7.1 mm Hg in the EX-PRESS and trabeculectomy groups, respectively ( P = 0.927). At 2 years after surgery, the success rate was 83% and 79% in the EX-PRESS and trabeculectomy groups, respectively ( P = 0.563). Although visual acuity (logMAR) was significantly decreased on day 1 in both groups, the vision was not significantly different compared with baseline at 1 month after EX-PRESS implant ( P = 0.285) and 3 months after trabeculectomy ( P = 0.255). The variance of early postoperative intraocular pressure values was similar between groups on the first postoperative day but higher after trabeculectomy compared with EX-PRESS implant on day 7 ( P = 0.003). The total number of postoperative complications was higher after trabeculectomy than after EX-PRESS implantation ( P = 0.013). Conclusions Mean intraocular pressures, medication use, and surgical success were similar at 2 years after treatment with the EX-PRESS device and trabeculectomy. Vision recovery between groups was also similar throughout the study, although return to baseline vision was more rapid in the EX-PRESS group. Intraocular pressure variation was lower during the early postoperative period, and postoperative complications were less common after EX-PRESS implantation compared with trabeculectomy.
To report interim 6-month safety and efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI
Surgical System concomitantly with phacoemulsification in patients with open-angle ...glaucoma (OAG).
Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin).
Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications.
Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline.
A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 ± 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a ≥ 20% reduction in IOP and 86% (89/104) had IOP ≥6 and ≤18 mmHg. The mean number of medications at screening was 1.8 ± 0.9 and 0.6 ± 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation ≥10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI.
Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.
To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) ...combined with cataract surgery as participants in the GEMINI study.
Eleven ophthalmology practices in 10 US states.
Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study.
GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP <33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21-36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥6 and ≤18 mmHg.
A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, -1.3) and 0.3 (36 months, -1.4). About 74% of patients (46 of 62) were medication free at 36 months.
GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.
The use of glaucoma drainage devices (GDD) in the treatment of glaucoma has become widely accepted for cases of refractory glaucoma. Expansion in the indications for implantation of GDD beyond ...refractory glaucoma is increasingly common. As such, tube implant complications are reviewed to aid in prevention and improve their management.
Findings of the Tube Versus Trabeculectomy study resulted in an expanded use of tube implants in cases of refractory glaucoma. As interest in GDD implantation flourished, so too, did investigative comparison between devices; which includes the Ahmed Baerveldt Comparison study and Ahmed Verses Baerveldt study. Comparative analysis of success and complication rates between implantable devices is not only expanding the technology of tube implants, but also building a body of evidence that tube implantation has a strong safety profile and usage among specialists will continue to increase and indications will evolve. Complications resulting from GDD implantation include hypotony, postoperative elevated intraocular pressure, tube erosion, diplopia, motility disturbances, and corneal decompensation.
Tube implant use is increasing and indications are expanding beyond refractory glaucoma. Understanding differences in GDD, their complications and management will result in improved patient care.
Purpose To evaluate the efficacy of achieving a 360° ab externo trabeculectomy using an illuminated ophthalmic microcatheter for the treatment of primary congenital glaucoma. Methods This ...retrospective, consecutive case series included 16 eyes of 10 patients ≤3 years of age at the time of surgery and diagnosed with primary congenital glaucoma. All patients underwent a trabeculectomy via microcatheter with the intent of catheterizing the full circumference of Schlemm’s canal and rupturing the entire canal in a single procedure. The main outcome measure was the success rate of achieving a complete 360° as compared to a partial trabeculectomy. Secondary outcome measures included intraocular pressure (IOP), glaucoma medication usage, and adverse events. Clinical examination data are reported up to 12 months postoperatively. Results Of 16 eyes included, 12 (75%) achieved a complete 360° trabeculectomy using the microcatheter; 4 of 16 eyes (25%) achieved a partial trabeculectomy. For all treated eyes the postoperative reduction in IOP from baseline was statistically significant at the 1-, 3-, and 6-month follow-up visits ( p < 0.001). At 6 months, IOP was significantly lower in the complete as compared to the partial trabeculectomy cohort ( p = 0.03). Conclusions A complete or partial trabeculectomy was safely completed in eyes with primary congenital glaucoma using a microcatheter with an illuminated, atraumatic tip.
Glaucoma drainage devices (GDDs) have been generally accepted as a treatment of refractory glaucoma. GDDs have their own unique set of complications that are important to evaluate to prevent them.
...Tube shunts are typically used in eyes with refractory glaucoma. There is increased interest in studying the efficacy of GDDs. Most of the attention has been focused on comparing trabeculectomy with the Baerveldt implant (Advanced Medical Optics, Inc., Santa Anna, California, USA). The other leading implant is the Ahmed Glaucoma Valve. There are several retrospective studies comparing these two devices and a prospective study is ongoing. There is great interest in the complication rate of tube shunts and these have been published both retrospectively and prospectively. Complications such as hypotony, diplopia, strabismus, proptosis, tube erosion, failure, corneal decompensation, endophthalmitis, and visual loss are all important and some have recently been reviewed in the literature. Moreover, the use of glaucoma drainage implants in the pediatric population has been evaluated.
Glaucoma drainage implants have been a powerful tool in our surgical fight to prevent blindness; however, they are not without complications or controversy.
The purpose of this study was to evaluate the safety and efficacy of microinvasive glaucoma surgery (MIGS) with 360° ab-interno trabeculotomy using the TRAB360 device as a stand-alone procedure in ...patients with refractory primary open-angle glaucoma (POAG) and preoperative IOP ≥18 mmHg.
This study evaluated patients treated in a tertiary-referral clinical practice setting.
This study is a retrospective analysis of 81 eyes.
Patients with refractory open-angle glaucoma underwent stand-alone 360° ab-interno trabeculotomy using the TRAB360 device. Effectiveness was determined by reduction in medicated IOP and the use of medications from baseline. Safety was determined by the rate of adverse events and secondary surgical interventions. The time points assessed were baseline and postoperative day 1, week 1, and months 1, 3, 6, and 12. A subgroup analysis was performed on eyes with medicated preoperative IOP values of ≥25 mmHg.
The reductions in IOP from 1 day to 12 months postoperatively were statistically significant compared to baseline values. The mean reduction in IOP at 12 months was 7.3±6.7 mmHg from baseline. At 12 months, 59% eyes achieved ≥20% reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline. The mean number of IOP-lowering medications was reduced from 1.7±1.3 at baseline to 1.1±1.0 at 12 months. At 12 months, 67% of eyes with preoperative IOP values of ≥25 mmHg achieved ≥20% reduction in IOP and IOP <18 mmHg with the same or fewer numbers of IOP-lowering medications compared with those at baseline. The most common adverse event for all eyes was mild, transient hyphema (57 eyes). During the first year after the procedure, 20 (25%) eyes were considered failures since they required reinterventions.
Trabeculotomy using the TRAB360 device resulted in significant IOP reductions up to 1 year with a favorable safety profile. The device is an effective stand-alone MIGS procedure for patients with refractory POAG.
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