New eye insert may ease pain after cataract surgery
NCT ID NCT05626478
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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50 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Feb 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Advanced Vision Care
Los Angeles, California, 90067, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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