Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery (NCT05626478) | Clinical Trial Compass
CompletedPhase 4
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
United States50 participantsStarted 2023-06-01
Plain-language summary
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* C…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested DEXTENZA, a dissolvable insert placed in the eye, instead of eye drops after cataract surgery — is that an option for my surgery, and how does it compare to the standard eye drop regimen you'd normally prescribe for me?
2The trial measured how well DEXTENZA reduced inflammation inside the eye and pain after cataract surgery — based on what this Phase 4 study found, do you feel there's enough evidence to consider it as safe and effective as traditional drops for my situation?
3The trial also tracked serious complications like cystoid macular edema and corneal swelling — were there any notable safety signals in studies like this one that I should weigh before choosing this approach?
4Since this was a Phase 4 trial, meaning it was studying a treatment already approved for use, does that change how you think about recommending it compared to newer or experimental options?
5I have specific concerns about remembering to use eye drops correctly after surgery — is this the kind of situation where a slow-release insert like DEXTENZA might be worth discussing as a more practical choice for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change in anterior chamber inflammation (Cell and Flare) scores