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.

Plain language summary

Study assessing the safety and the intraocular pressure lowering effect of administering a travoprost intracameral implant in combination with having cataract surgery in patients with open-angle glaucoma or ocular hypertension

Why was the study done? The travoprost intracameral implant is a drug delivery system that is placed directly in the eye to continuously release travoprost to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Cataract surgery also is known to lower intraocular pressure in normal eyes and to a greater extent in eyes with glaucoma or ocular hypertension. Placement of the implant in the anterior chamber angle of the eye and cataract surgery are both done through a small corneal incision. What did the researchers do? The researchers studied the safety and the reduction in intraocular pressure after administering a travoprost intracameral implant during the same procedure as removal of the cataractous lens and administration of an intraocular lens. Sixty patients with open-angle glaucoma had the combined procedure and were followed over a 3-month period to check their intraocular pressure and health of their eye.

What did the researchers find? There were no serious safety findings after the combined procedure, with less than 10% of patients having any ocular side effect. The most common side effect was dry eye. At month 3, mean intraocular pressure was reduced significantly from the untreated baseline pressure measured before the combined procedure. What do the findings mean? The study showed that it is safe to combine the placement of the travoprost intracameral implant in the eye during the same procedure as routine cataract surgery. The study also showed that there was a substantial lowering of intraocular pressure at 3 months in patients with open-angle glaucoma.

Search results

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