A long-term evaluation of a travoprost intracameral implant has demonstrated sustained efficacy and safety in reducing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The study, which followed patients for 12 months, suggests that the implant could offer a valuable alternative to traditional topical medications for managing IOP.
The prospective study included patients diagnosed with OAG or OHT, with specific inclusion criteria such as a cup-to-disc ratio no greater than 0.8, visual field mean deviation no worse than -12 dB, and IOP between 21 and 36 mmHg after a washout period from previous medications. Exclusion criteria included prior glaucoma surgery, significant corneal or retinal disorders, and uncontrolled systemic disease.
Study Design and Procedures
Patients were randomized in a 1:1:1 ratio to receive either a fast-eluting (FE) travoprost implant, a slow-eluting (SE) travoprost implant, or a sham procedure. Those in the sham group received timolol maleate ophthalmic solution, 0.5%, while the implant groups received placebo eye drops. The implants were administered via a temporal clear corneal incision, with the implant anchored into the sclera at the iridocorneal angle under gonioscopic visualization. IOP was measured using Goldmann applanation tonometry at various time points throughout the study.
Key Findings
The primary outcome was the change from baseline in mean diurnal IOP. The results showed that both the FE and SE travoprost implants were non-inferior to timolol in reducing IOP over the 12-month period. The implants also demonstrated a favorable safety profile, with adverse events being generally mild and manageable.
Specifically, non-inferiority was declared if the upper limit of the two-sided 95% confidence interval (CI) around the difference (implant group minus sham/timolol group) in mean change from baseline in mean diurnal IOP was < 1.5 mmHg at each visit (day 10, week 6, month 3, and month 12).
Clinical Implications
These findings suggest that the travoprost intracameral implant is a promising option for patients with OAG or OHT who may benefit from a sustained-release medication delivery system. This approach could improve adherence and reduce the burden associated with topical eye drops, potentially leading to better long-term outcomes in glaucoma management.
