Intermediate-Term Outcomes of an Affordable Aqueous Drainage Implant in Adults with Refractory Glaucoma.

PURPOSE

To report the outcomes of Aurolab Aqueous Drainage Implant (AADI) (Aurolab, Madurai, India) surgery in adults with refractory glaucoma.

DESIGN

Retrospective, noncomparative, interventional case series.

PARTICIPANTS

Patients 18 years of age or older who underwent AADI surgery between January 2012 and December 2015 for refractory glaucoma with a minimum follow-up of 2 years.

METHODS

Case records of eligible patients were evaluated for demographics, best-corrected visual acuity (BCVA), and indication for AADI surgery. The intraocular pressure (IOP) and the number of antiglaucoma medications (AGMs) were recorded at baseline, at 1, 3, 6, 9, 12, 18, and 24 months, and at the last visit after 24 months if any from the case files. Complications during or at any time point after surgery were also recorded.

MAIN OUTCOME MEASURES

Cumulative failure rate of the AADI was defined as IOP > 18 mmHg or not reduced by 30% below baseline on 2 consecutive follow-up visits after 3 months, IOP ≤ 6 mmHg on 2 consecutive follow-up visits after 3 months, reoperation for glaucoma, or loss of light perception vision.

RESULTS

A total of 158 eyes of 158 patients with a mean age of 45.4±17.4 years and mean follow-up of 41.9±14.7 months were included in the analysis. Secondary open-angle glaucoma (n = 71, 45%) was the most common form of glaucoma. The mean preoperative IOP was 34.7±9.9 mmHg with 3.2±0.7 AGMs. At 1 year, the mean IOP decreased to 15.10±6.7 mmHg with 1.5±1.1 medications, and this was maintained at 2 years. Kaplan-Meier estimates showed that the cumulative probability of failure was 9.5% (95% confidence interval [CI], 5.8-15.2) at 1 year, 27.8% (95% CI, 21.5-35.5) at 2 years, 38.9% (95% CI, 31.1-47.8) at 3 years, and 50.1% (95% CI, 40.5-60.6) at 4 years. Forty-seven complications were observed in 38 eyes (24%), most of which were transient and did not require surgical intervention. The AADI tube exposure (n = 1), retraction (n = 1), plate exposure (n = 1), and plate displacement (n = 1) were seen rarely.

CONCLUSIONS

The AADI appears to have good efficacy and safety for managing eyes with refractory glaucoma. Longer follow-up studies are required to determine long-term cumulative failure rates.