Excimer Laser Trabeculostomy Glaucoma Treatment Study

Not Applicable

Active, not recruiting

• Conditions: Glaucoma, Primary Open Angle
• Interventions: Device: ELIOS Procedure

• Registration Number: NCT04899063
• Lead Sponsor: Elios Vision, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-10
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Primary Completion: 2024-06-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 318

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELIOS Procedure	ELIOS Procedure	ELIOS Procedure

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%	24 Month	Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20%

Secondary Outcome Measures

Name	Time	Method
Mean Change in medication-free DIOP from baseline	24 Month	Mean change in medication-free DIOP from baseline

Trial Locations

Locations (2)

ELIOS Vision Clinical Site; 🇺🇸 Kenosha, Wisconsin, United States

Elios Vision Clinical Site 2; 🇺🇸 San Antonio, Texas, United States