Excimer Laser Trabeculostomy Glaucoma Treatment Study

NCT ID: NCT04899063

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2025-07-29

Brief Summary

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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

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Conditions

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Glaucoma, Primary Open Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ELIOS Procedure

ELIOS Procedure

Group Type OTHER

ELIOS Procedure

Intervention Type DEVICE

Treatment with the ELIOS System

Interventions

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ELIOS Procedure

Treatment with the ELIOS System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elios Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iqbal (Ike) Ahmed, MD

Role: STUDY_DIRECTOR

Prism Eye Institute

Locations

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ELIOS Vision Clinical Site

Glendale, Arizona, United States

Site Status

ELIOS Vision Clinical Site

Petaluma, California, United States

Site Status

ELIOS Vision Clinical Site

Fort Collins, Colorado, United States

Site Status

ELIOS Vision Clinical Site

Grand Junction, Colorado, United States

Site Status

ELIOS Vision Clinical Site

DeLand, Florida, United States

Site Status

ELIOS Vision Clinical Site

Largo, Florida, United States

Site Status

ELIOS Vision Clinical Site

Melbourne, Florida, United States

Site Status

ELIOS Vision Clinical Site

Vero Beach, Florida, United States

Site Status

ELIOS Vision Clinical Site

Rock Island, Illinois, United States

Site Status

ELIOS Vision Clinical Site

Overland Park, Kansas, United States

Site Status

ELIOS Vision Clinical Site

Chaska, Minnesota, United States

Site Status

ELIOS Vision Clinical Site

St Louis, Missouri, United States

Site Status

ELIOS Vision Clinical Site

Las Vegas, Nevada, United States

Site Status

ELIOS Vision Clinical Site

South Orange, New Jersey, United States

Site Status

ELIOS Vision Clinical Site

Oklahoma City, Oklahoma, United States

Site Status

ELIOS Vision Clinical Site

Duncanville, Texas, United States

Site Status

ELIOS Vision Clinical Site

El Paso, Texas, United States

Site Status

Elios Vision Clinical Site 2

San Antonio, Texas, United States

Site Status

ELIOS Vision Clinical Site

San Antonio, Texas, United States

Site Status

ELIOS Vision Clinical Site

Kenosha, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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EP-01

Identifier Type: -

Identifier Source: org_study_id

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