Glaucoma, Primary Open Angle Clinical Trial
— ELTGTSOfficial title:
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery
Verified date | August 2023 |
Source | Elios Vision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 318 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | ELIOS Vision Clinical Site | Chaska | Minnesota |
United States | ELIOS Vision Clinical Site | DeLand | Florida |
United States | ELIOS Vision Clinical Site | Duncanville | Texas |
United States | ELIOS Vision Clinical Site | El Paso | Texas |
United States | ELIOS Vision Clinical Site | Fort Collins | Colorado |
United States | ELIOS Vision Clinical Site | Glendale | Arizona |
United States | ELIOS Vision Clinical Site | Grand Junction | Colorado |
United States | ELIOS Vision Clinical Site | Kenosha | Wisconsin |
United States | ELIOS Vision Clinical Site | Largo | Florida |
United States | ELIOS Vision Clinical Site | Las Vegas | Nevada |
United States | ELIOS Vision Clinical Site | Melbourne | Florida |
United States | ELIOS Vision Clinical Site | Oklahoma City | Oklahoma |
United States | ELIOS Vision Clinical Site | Overland Park | Kansas |
United States | ELIOS Vision Clinical Site | Petaluma | California |
United States | ELIOS Vision Clinical Site | Rock Island | Illinois |
United States | ELIOS Vision Clinical Site | Saint Louis | Missouri |
United States | ELIOS Vision Clinical Site | San Antonio | Texas |
United States | Elios Vision Clinical Site 2 | San Antonio | Texas |
United States | ELIOS Vision Clinical Site | South Orange | New Jersey |
United States | ELIOS Vision Clinical Site | Vero Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Elios Vision, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | 24 Month | |
Secondary | Mean Change in medication-free DIOP from baseline | Mean change in medication-free DIOP from baseline | 24 Month |
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