RecruitingPhase 4NCT06848946

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone


Sponsor

Glaukos Corporation

Enrollment

132 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone


Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for people who need cataract surgery and also have glaucoma or elevated eye pressure: cataract surgery plus implantation of a tiny sustained-release glaucoma medication device (iDose TR) versus cataract surgery alone — to see if the combined approach better controls eye pressure. **You may be eligible if...** - You have a clinically significant cataract in one eye that needs surgery - You also have open-angle glaucoma (primary, pseudoexfoliation, or pigmentary type) or elevated eye pressure (ocular hypertension) in the same eye - You are scheduled for phacoemulsification (standard cataract removal surgery) **You may NOT be eligible if...** - Your glaucoma is a type other than open-angle (e.g., narrow-angle, neovascular, or traumatic) - You have had prior glaucoma surgery in the study eye - You have other significant eye conditions that would affect the study results - You are unable to attend required follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTiDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery

PROCEDURESham procedure in conjunction with cataract surgery

Sham procedure in conjunction with cataract surgery


Locations(1)

Glaukos Investigator Site

Kenosha, Wisconsin, United States

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NCT06848946


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