iStent inject trabecular micro-bypass stents with topical prostaglandin as standalone treatment for open-angle glaucoma: 4-year outcomes.

IMPORTANCE

Long-term data are needed regarding effective and safe glaucoma treatment modalities.

BACKGROUND

This study evaluated 4-year outcomes of second-generation trabecular micro-bypass stent implantation (iStent inject) combined with topical travoprost in open-angle glaucoma (OAG).

DESIGN

Prospective, non-randomized, multi-surgeon study at a tertiary care ophthalmology centre.

PARTICIPANTS

OAG subjects with preoperative intraocular pressure (IOP) 18 to 30 mmHg on two medications and 22 to 38 mmHg post-washout.

METHODS

Subjects (n = 53) underwent standalone iStent inject implantation and started travoprost on postoperative Day 1. Measures included IOP, medications, comprehensive ophthalmic examinations and testing, and adverse events (AEs). Annual medication washouts were performed.

MAIN OUTCOME MEASURES

Mean medicated and unmedicated IOP; and proportions of eyes with IOP ≤18mmHg, ≤15 mmHg, or ≥20% reduced while on travoprost vs screening IOP on two medications.

RESULTS

At 48 months postoperative, 85% of eyes reduced IOP ≥20% on travoprost vs screening IOP on 2 medications; 92% of eyes had IOP ≤18 mmHg on travoprost; and 83% had IOP ≤15 mmHg on travoprost. At Month 49 (post-washout), 90% of eyes reduced IOP ≥20% vs preoperative washout IOP. Throughout follow-up, mean IOP on travoprost was 11.9 to 13.0 mmHg (34%-40% reduced vs 19.7 mmHg on 2 medications preoperatively; P < .0001 throughout), and post-washout IOP was 16.5 to 17.7 mmHg (28%-34% reduced vs 24.9 mmHg preoperatively; P < .0001 throughout). Favourable safety included minimal AEs; stable visual acuity, cup-to-disc ratio and visual fields; and no secondary surgeries.

CONCLUSIONS AND RELEVANCE

Combining iStent inject implantation with topical prostaglandin produced significant and safe 4-year IOP and medication reductions in OAG.