Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New eye implant could replace drops after retina surgery

NCT ID NCT04371445

Symptom relief Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests a tiny gel-like insert placed in the tear duct that releases dexamethasone, a steroid, to reduce pain and swelling after vitreoretinal surgery. It compares the insert to standard steroid eye drops in 30 adults undergoing surgery for conditions like macular holes or epiretinal membranes. The goal is to see if the insert controls inflammation and pain as well as drops, with less hassle.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexamethasone ophthalmic insert (DEXTENZA)
What this could lead to
If it works, this could offer a more convenient way to manage pain and inflammation after eye surgery, potentially replacing daily eye drops.
What could go wrong
This is a small, early-phase study with only 30 participants, so results may not apply to everyone. The insert may not control inflammation as well as drops, and there is a risk of side effects like increased eye pressure or infection.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Men and women \>18 years old * Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction. Exclusion Criteria: * Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system * History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye * Structural lid abnormalities such as ectropion or entropion in surgical eye * Ongoing use of systemic narcotic pain relievers * Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline * Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline * Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes * Other ocular surgeries or procedures during the study period and/or 6 months prior * Intraoperative complications * Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled. * Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication. * Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery. * Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively. * Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure * Are pregnant or nursing/lactating * Participation as a subject in any clinical study within the 30 days prior to randomization. * Surgeries using 20 gauge or 23 gauge instruments.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Epiretinal membrane are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

macular holes Pain, Postoperative preretinal fibrosis

As listed by the trial registrant

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

Ocular inflammation Post operative pain Post-operative inflammation Vitreoretinal surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cole Eye Institute, Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.