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Glaucoma device showdown ends early: only 10 patients enrolled

NCT ID NCT04658095

Disease control Sponsor: Sight Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to compare two surgical devices—the OMNI system and the iStent inject—for lowering eye pressure in people with open-angle glaucoma who already had cataract surgery. The trial was terminated early and only enrolled 10 participants, so results are limited. Both devices are designed to help control glaucoma, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Jan 2022

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects, 18 years or older 2. Pseudophakic 3. Diagnosis of open angle glaucoma (OAG) 4. On 1-5 ocular hypotensive medications Exclusion Criteria: 1. Any of the following prior treatments for glaucoma: * Suprachoroidal stent (e.g. Cypass, iStent Supra) * Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass * Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve * Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome * Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU) 2. Any other form of glaucoma other than OAG 3. 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). 4. 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.

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Conditions

The condition(s) this trial relates to.

open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glaucoma, open-angle

Contacts and locations

Locations

  • BurgerHospital

    Frankfurt, Germany

  • Institut Catala de Retina (ICR)

    Barcelona, 08022, Spain

  • Manchester Royal Eye Hospital

    Manchester, M13, United Kingdom

  • Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle

    Zaragoza, 50009, Spain

  • Universidad Complutense de Madrid

    Valencia, 46026, Spain

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