CompletedNot Applicable

Excimer Laser Trabeculostomy Glaucoma Treatment Study

United States318 participantsStarted 2021-05-10

Plain-language summary

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery

Who can participate

Age range45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of mild to moderate POAG * Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse * Medicated IOP of \<=24 mmHg * Unmedicated diurnal IOP of \>=22 mmHg and \<=34 mmHg * Shaffer angle grade of III or IV * CD ratio \<=0.8 * At least 45 years old Exclusion Criteria: * Closed-angle and secondary glaucomas * Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery * Cannot undergo medication washout in the study eye * Diagnosis of degenerative visual disorders * Non-study eye with BCVA worse than 20/80 * Known corticosteroid responder * Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control

What they're measuring

Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%

Timeframe: 24 Month

Trial details

NCT IDNCT04899063

SponsorElios Vision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-29

View on ClinicalTrials.gov More Glaucoma, Primary Open Angle trials