Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Foll… (NCT07696104) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Nonsteroidal Anti-Inflammatory Drugs for the Prevention of Cystoid Macular Edema Following Cataract Phacoemulsification
Poland88 participantsStarted 2020-10-14
Plain-language summary
This randomized clinical study evaluated the effectiveness of different postoperative nonsteroidal anti-inflammatory drug (NSAID) regimens in patients undergoing uncomplicated phacoemulsification cataract surgery. Eighty-eight eligible participants were randomly assigned to one of four treatment groups using a simple dice-based randomization procedure: bromfenac 0.09% twice daily for 2 weeks, bromfenac 0.09% twice daily for 4 weeks, diclofenac 0.1% four times daily for 4 weeks, or nepafenac 0.1% three times daily for 4 weeks. All patients received the same standard perioperative care and adjunctive dexamethasone treatment. The primary outcome was central subfield thickness (CST) measured by spectral-domain optical coherence tomography (OCT) at 6 and 12 weeks after surgery. Secondary outcomes included best-corrected distance visual acuity, refraction, and intraocular pressure.
Who can participate
Age range
30 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
. Adults scheduled for elective uncomplicated phacoemulsification cataract surgery.
. Ability and willingness to provide written informed consent.
. No abnormalities detected on preoperative anterior segment examination.
. No abnormalities detected on preoperative posterior segment examination.
. Willingness and ability to attend follow-up visits at 6 and 12 weeks after cataract surgery.
Exclusion criteria
. Systemic diseases that could affect the macula (e.g. diabetes).
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.
What they're measuring
1
Changes in Central Subfield Thickness After Cataract Surgery
Timeframe: Baseline (preoperative), 6 weeks, and 12 weeks after uncomplicated phacoemulsification cataract surgery