Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery.

Abstract

Background: The travoprost intracameral implant and cataract surgery both lower intraocular pressure (IOP).

Objectives: We evaluated the safety and IOP-lowering effect at 3 months following administration of travoprost intracameral implant in combination with cataract surgery.

Design: Prospective, 12-month, open-label, single-arm trial.

Methods: We enrolled patients with age-related cataracts and open-angle glaucoma or ocular hypertension in the same eye. At baseline, patients were required to have an unmedicated mean diurnal IOP (average of 8:00 am, 10:00 am, and 4:00 pm IOPs) of 24 mmHg or greater, and an IOP of 36 mmHg or less at each of these three timepoints. On the day of the combined procedure (day 1), patients who had uncomplicated phacoemulsification cataract surgery received a travoprost intracameral implant. Follow-up evaluations occurred on day 2-3, week 2, week 6, and month 3 visits.

Results: Sixty patients had uncomplicated cataract surgery and received a travoprost intracameral implant. There were no serious adverse events. Study eye adverse events were reported in 8.3% of patients. The most frequently reported adverse event was dry eye (6.7%). At month 3, the mean diurnal IOP change from baseline was -10.6 mmHg (95% confidence interval: -11.2, -9.9; p < 0.0001) from an unmedicated baseline mean diurnal IOP of 25.2 mmHg. In addition, at month 3, 97% of eyes had a 20% or greater mean diurnal IOP reduction from baseline, and 91.0% of eyes had a mean diurnal IOP of 18 mmHg or less.

Conclusion: Administration of a travoprost intracameral implant combined with routine cataract surgery was safe. The sizable -10.6 mmHg IOP change from baseline at month 3 was both statistically significant and clinically relevant.

Trial registration: NCT06061718, Travoprost Intraocular Implant in Conjunction with Cataract Surgery, https://clinicaltrials.gov/study/NCT06061718.