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 (ELTGTS)

  • End date
    Jul 12, 2024
  • participants needed
  • sponsor
    Elios Vision, Inc.
Updated on 12 October 2022


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 Glaucoma, Primary Open Angle
Treatment ELIOS Procedure
Clinical Study IdentifierNCT04899063
SponsorElios Vision, Inc.
Last Modified on12 October 2022


Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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