Surgical Outcomes of a New Low-Cost Nonvalved Glaucoma Drainage Device in Refractory Glaucoma: Results at 1 Year

Abstract

Purpose: The purpose of this study was to report the early outcomes in terms of efficacy and safety of a new, indigenously manufactured, low-cost nonvalved drainage device [AADI (Aurolab Aqueous Drainage Implant)] in the management of refractory glaucoma in the Indian population.

Methods: Retrospective review of consecutive patients older than 12 years, who underwent glaucoma drainage device surgery (GDD) using AADI, by a single fellowship-trained surgeon, between January 2014 and December 2016, who had at least 3 months of documented post-op follow-up.

Outcome measures: Primary-intraocular pressure (IOP).Secondary-number of antiglaucoma medication (AGM), LogMAR best corrected visual acuity (BCVA), and complications.Complete success was defined as IOP ≥5 mm Hg and ≤21 mm Hg or reduction of IOP by ≥20% from baseline without AGM; qualified success with use of AGM. Failure was defined as inability to meet IOP criteria, loss of perception of light, explantation or any additional glaucoma surgery.

Results: A total of 54 eyes of 51 patients were included. Mean follow up was 12.1±6.3 months. The IOP and number of AGM required was significantly lower at every visit postoperatively (P<0.001). Median LogMAR BCVA remained unchanged (P=0.5). Complications occurred in 22 patients (40.7%). Complete success was seen in 66.6%; overall success was 92.6%.

Conclusions: New nonvalved GDD (AADI) surgery is effective in reducing IOP and need for AGM with a safety profile similar to published reports of prevailing GDDs. It thus has the ability to breach the cost barrier in low-to-middle income countries; further follow-up is required to determine sustainability over time.