TerminatedNot Applicable

Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

Stopped: Business Decision

Germany, Spain, United Kingdom10 participantsStarted 2022-01-11

Plain-language summary

First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female subjects, 18 years or older
✓. Pseudophakic
✓. Diagnosis of open angle glaucoma (OAG)
✓. On 1-5 ocular hypotensive medications

Exclusion criteria

✕. Any of the following prior treatments for glaucoma:
✕. Any other form of glaucoma other than OAG
✕. Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
✕. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.

What they're measuring

Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination

Timeframe: 12 months

Trial details

NCT IDNCT04658095

SponsorSight Sciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-18

Results submitted2025-08-12

View on ClinicalTrials.gov More Glaucoma, Open-Angle trials