"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard… (NCT04781335) | Clinical Trial Compass
CompletedPhase 4
"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"
United States25 participantsStarted 2020-02-20
Plain-language summary
Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antibiotics. Those are used to decrease the possibility of infection, inflammation that may lead to corneal and macular edema and pain management. There are several FDA approved agents either for topical use as single drug delivery or combination solutions for topical use as well; furthermore, there are slow release vehicles that may be placed at the time of surgery or postoperatively (at the lower punctum). The latter provides a less intense and demanding drop schedule and may improve patient compliance.
Who can participate
Age range
40 Years – 90 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:
* • Patients age 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery
Exclusion Criteria:
* • Patients with history of diabetes mellitus and other systemic conditions that may promote inflammation
* patients with previous ocular disease history
* patients with history of ocular surgery
* patients using prescription eye medications topically
* vulnerable subjects or subjects with diminished capacity requiring a POA (Power of Attorney)
* patients with allergies to steroids, NSAID's, or besifloxacin (standard antibiotic)
* women who are pregnant or lactating
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.