Excimer Laser Trabeculostomy Glaucoma Treatment Study

Elios Vision, Inc.318 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

318

Conditions

Glaucoma, Primary Open Angle

Interventions

ELIOS ProcedureDEVICE

Treatment with the ELIOS System

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (20)

ELIOS Vision Clinical Site

Glendale, Arizona, United States

ELIOS Vision Clinical Site

Outcomes

Primary Outcomes

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

Time frame: 24 Month

Secondary Outcomes

Mean Change in medication-free DIOP from baseline

Mean change in medication-free DIOP from baseline

Time frame: 24 Month

Data from ClinicalTrials.gov

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