36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma.

Purpose: 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. Setting: Eleven ophthalmology practices in 10 US states. Design: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study. Methods: 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. Results: 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. Conclusion: 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.

Real-World Outcomes of Canaloplasty and Trabeculotomy Combined with Cataract Surgery in Eyes with All Stages of Open-Angle Glaucoma.

Purpose: To evaluate the long-term safety and efficacy of sequential canaloplasty and trabeculotomy combined with cataract surgery in patients with mild, moderate, and advanced open-angle glaucoma. Patients and Methods: Case records of 171 consecutive patients (171 eyes) who had undergone cataract surgery followed by canaloplasty (≥180°) and trabeculotomy (≥90°) for mild, moderate, or advanced open-angle glaucoma (Shaffer grade ≥3) using the OMNI Surgical System (Sight Sciences, Inc., Menlo Park, CA) were analyzed retrospectively. Efficacy endpoints included change in mean IOP and number of medications from baseline to postoperative 12- and 24-months for the overall dataset and stratified by each stage of glaucoma. Kaplan-Meier survival analysis of success (eyes that did not require secondary surgical interventions (SSI)) by postoperative 24 months was also performed. Results: Postoperatively, there was a statistically significant reduction in IOP (baseline of 17.2 mmHg on 1.3 medicines reduced to 14.3 on 0.8 medicines (12 months) and 14.0 on 0.9 medicines (24 months), p<0.001 for both time points). Eyes with advanced glaucoma (N=63) maintained significant IOP reduction (17.8 mmHg on 1.6 medicines at baseline reduced to 13.6 mmHg on 1.3 medicines (12 months) and 13.0 on 1.5 medicines (24 months), p<0.001). Kaplan-Meier analysis showed a 93.0% survival probability for the avoidance of SSI at 2 years after surgery. Conclusion: Canaloplasty and trabeculotomy combined with cataract surgery provided effective IOP reduction for eyes with all stages of glaucoma at postoperative 12 and 24 months, and the procedure yielded a 93% survival rate for SSI avoidance at 2 years.

Suture Stenting of a Tube Fenestration for Early Intraocular Pressure Control After Baerveldt Glaucoma Implant Surgery.

PURPOSE: To evaluate the efficacy and safety of a tube fenestration stented with a 10-0 polyglactin suture for controlling early postoperative intraocular pressure (IOP) after Baerveldt glaucoma implant (BGI) surgery. METHODS: The medical records of 110 patients (119 eyes) who underwent BGI surgery with a tube fenestration stented with a 10-0 polyglactin suture anterior to an occlusive tube ligature were retrospectively reviewed. Main outcome measures included IOP and number of glaucoma medications at postoperative day 1, week 1, and weeks 2 to 3 as well as complications occurring before ligature release. RESULTS: Mean±SD preoperative IOP was 30.9±9.3 mm Hg using an average of 3.8±1.1 glaucoma medications. A statistically significant reduction in IOP and glaucoma medications was observed at all timepoints during the first 3 postoperative weeks compared with baseline (P<0.001). Mean IOP on postoperative day 1, week 1, and weeks 2 to 3 was 18.4±12.2 mm Hg on no medication, 15.9±9.4 mm Hg on 1.0±1.3 medications, and 16.7±8.2 mm Hg on 1.2±1.5 medications, respectively. In total, 44 eyes (37%) achieved IOP control without glaucoma medication during period of tube occlusion. CONCLUSIONS: The use of a single, monofilament 10-0 polyglactin suture to stent a fenestration proximal to the occlusive ligature of a BGI tube is effective in controlling IOP in the early postoperative period. Hypotony-related complications were infrequent and resolved in all cases with in-office interventions.

Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma.

AIM: To describe postoperative surgical success of either Ahmed or Baerveldt tube shunt implantation for eyes with medically uncontrolled traumatic glaucoma. MATERIALS AND METHODS: A review was carried out to identify patients with traumatic glaucoma that required tube shunt implantation between 2009 and 2015 at Rutgers University in Newark, New Jersey, USA. Seventeen eyes from 17 patients met inclusion criteria, including at least 3-month postoperative follow-up. The main outcome measure was surgical success at 1-year follow-up after tube implantation. RESULTS: Mean preoperative intraocular pressure (IOP) was 34.1 ± 8.2 mm Hg on 3.1 ± 1.6 ocular hypotensive medications. Nine eyes (53%) sustained closed globe injury. Ten eyes (59%) received an Ahmed valve shunt and seven eyes (41%) received a Baerveldt tube shunt. Surgical success rate at 1 year postoperatively was 83%. Compared to preoperative, the mean postoperative IOP was significantly lower (16.1 ± 3.5 mm Hg, p < 0.001) on significantly fewer ocular hypertensive medications (1.3 ± 1.6, p = 0.001) at a mean follow-up of 10 months. Mean IOP reduction at last follow-up was 49%. There were three cases of surgical failures: One case of hypotony, one case of tube extrusion with subsequent explan-tation, and one case requiring second tube insertion for IOP control. CONCLUSION: Implantation of an Ahmed or Baerveldt tube shunt provided successful control of IOP in patients with medically uncontrollable traumatic glaucoma. HOW TO CITE THIS ARTICLE: Yadgarov A, Liu D, Crane ES, Khouri AS. Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma. J Curr Glaucoma Pract 2017;11(1):16-21.