New eye insert may ease pain after cataract surgery

NCT ID NCT05626478

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 ยท Last updated Jun 27, 2026

Summary

This study tested whether a tiny eye insert called DEXTENZA, placed after cataract surgery, works better than standard eye drops alone for reducing pain and swelling. Fifty adults having cataract surgery took part. The insert slowly releases medicine over time, aiming to improve comfort and recovery.

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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

50 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2025

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: * Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes * Are willing and able to comply with clinic visits and study related procedures * Are willing and able to sign the informed consent form Exclusion Criteria: * Under the age of 18 at the time of signing the Informed Consent Form * Pregnant or planning to become pregnant during the trial period * Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing * Have active infectious systemic disease * Have active infectious ocular or extraocular disease * Have punctal plug in the study eye * Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus) * Have known hypersensitivity to dexamethasone or are a known steroid responder * Have a history of ocular inflammation or macular edema * Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye * Are currently being treated with immunomodulating agents in the study eye * Are currently being treated with immunosuppressants and/or oral steroids * Are currently being treated with corticosteroid implant (i.e Ozurdex) * Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye * Have a history of complete punctal occlusion in one or both punctum * Currently using topical ophthalmic steroid medications * Are unwilling or unable to comply with the study protocol * Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Advanced Vision Care

    Los Angeles, California, 90067, United States

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