Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04899063
Other study ID # EP-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 10, 2021
Est. completion date June 2025

Study information

Verified date August 2023
Source Elios Vision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Intervention

Device:
ELIOS Procedure
Treatment with the ELIOS System

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Elios Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT02679482 - Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma N/A
Recruiting NCT05999006 - Safety and Feasibility of the ELIOS System in POAG Patients N/A
Completed NCT05181046 - Evaluation of Nanodropper-mediated Microdrops vs. Standard Drops of 0.5% Timolol Maleate in Glaucoma Patients N/A
Completed NCT01999348 - A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
Completed NCT04149899 - Safety and IOP-Lowering Effects of WB007 Phase 1/Phase 2
Not yet recruiting NCT04007276 - The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Phase 4
Completed NCT01814761 - A Study of Bimatoprost 0.01% in the Clinical Setting Phase 4
Completed NCT05474716 - The Effect of Topical Brimonidine on the Ocular Hemodynamics in Patients of POAG Using OCTA Phase 4
Recruiting NCT03067415 - Exploratory Trial to Evaluate the Efficacy and Safety of D565H Twice Daily Versus D565 Once Daily Phase 2
Not yet recruiting NCT06053307 - Treating Psychosocial Distress in Glaucoma N/A
Completed NCT02796560 - Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Phase 4
Terminated NCT02858284 - Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension N/A
Recruiting NCT05370287 - Adaptive Optics Retinal Imaging N/A
Not yet recruiting NCT05673954 - Glaucoma Assessment Via Reading Ability
Active, not recruiting NCT03318510 - LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma N/A
Active, not recruiting NCT03151577 - Longitudinal Study on Glaucoma Surgery Using XEN® Gel Stent N/A
Completed NCT04465864 - Investigate, Following Cataract Surgery With IOL in Conjunction With Intracanalicular Dexamethasone Insert Phase 4
Recruiting NCT03675412 - Caffeine Consumption in Glaucoma Patients and Healthy Subjects N/A
Completed NCT01833741 - A Study of LUMIGAN® RC in the Clinical Setting Phase 4
Completed NCT03800589 - Assessment of Effectiveness Ex-Press Surgery Modification N/A