Two-Year Data on the Efficacy and Safety of the MINIject Supraciliary Implant in Patients with Medically Uncontrolled Primary Open-Angle Glaucoma.

Background/

Objectives

The aim of this study is to evaluate the long-term efficacy and safety of the MINIject supraciliary device in patients with medically uncontrolled primary open-angle glaucoma (POAG) with up to 2 years of follow-up.

Methods

A retrospective study was conducted using electronic medical records. Patients with medically uncontrolled POAG were included. Patients were either phakic, receiving combined phacoemulsification and MINIject, or pseudophakic receiving standalone MINIject. They were followed up for 24 months postoperatively. The primary outcomes were intraocular pressure (IOP) and use of IOP-lowering medications at 24 months postoperatively. Other secondary outcomes included IOP and use of glaucoma medications at 6, 12, and 18 months, success defined as 6 ≤ IOP ≤ 18 mmHg without the use of medications (complete) or regardless of the use of medications (qualified), average change in visual field (VF) mean deviation (MD) from baseline to 24 months, and adverse events.

Results

The study included 37 eyes of 37 consecutive glaucoma patients. Of these, 27 underwent combined phacoemulsification with MINIject implantation and 10 had standalone MINIject. The mean preoperative IOP was 17.95 ± 4.75 mmHg on 2.16 ± 1.12 glaucoma drops. At 24 months, the mean IOP was 14.58 ± 4.55 on 0.69 ± 0.98 medications (p = 0.002). No difference in IOP was noted between the combined and the standalone group, although the latter had a trend for more glaucoma drops. The qualified success and the complete success rates were 67.6% and 56.8%, respectively. Average VF mean deviation progression was 0.19 ± 1.19 dB. No sight threatening complications occurred.

Conclusions

MINIject can be a safe and effective alternative to current glaucoma devices, offering significant reduction in IOP and medication use with a good safety profile. Longer term data are needed to confirm its prolonged safety.