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Excimer Laser Trabeculostomy Glaucoma Treatment Study (ELTGTS)

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ClinicalTrials.gov Identifier: NCT04899063
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Glaucoma, Primary Open Angle Device: ELIOS Procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Device: ELIOS Procedure
    Treatment with the ELIOS System


Primary Outcome Measures :
  1. Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% [ Time Frame: 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 :
  1. Mean Change in medication-free DIOP from baseline [ Time Frame: 24 Month ]
    Mean change in medication-free DIOP from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899063


Contacts
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Contact: Rupali Nangia 714-227-6151 rupali@eliosvision.com

Locations
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United States, Arizona
ELIOS Vision Clinical Site Recruiting
Glendale, Arizona, United States, 85306
United States, Colorado
ELIOS Vision Clinical Site Recruiting
Fort Collins, Colorado, United States, 80528
United States, Kansas
ELIOS Vision Clinical Site Recruiting
Overland Park, Kansas, United States, 66213
United States, Missouri
ELIOS Vision Clinical Site Recruiting
Saint Louis, Missouri, United States, 63131
United States, Oklahoma
ELIOS Vision Clinical Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
ELIOS Vision Clinical Site Recruiting
El Paso, Texas, United States, 79902
United States, Wisconsin
ELIOS Vision Clinical Site Recruiting
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Elios Vision, Inc.
Investigators
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Study Director: Iqbal (Ike) Ahmed, MD Prism Eye Institute
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Responsible Party: Elios Vision, Inc.
ClinicalTrials.gov Identifier: NCT04899063    
Other Study ID Numbers: EP-01
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD planned to be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases