TerminatedPhase 3

Effectiveness of Periocular Drug Injection in CATaract Surgery

Stopped: Results of interim analysis: stop the trial due to one group being significantly different from the other three groups. Furthermore, shortage of study medication.

Austria, Germany, Netherlands628 participantsStarted 2021-10-13

Plain-language summary

Cystoid macular edema (CME) is a major cause of suboptimal postoperative visual acuity after cataract surgery. Topical steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) are used to prevent CME. However, noncompliance with eye drops may compromise the effectiveness of treatment. Dropless periocular drug delivery during cataract surgery may improve the outcomes and cost-effectiveness of cataract surgery, and may alleviate the burden on homecare organizations.

Who can participate

Age range

21 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: * who are undergoing routine phacoemulsification (one eye per patient); * who are 21 years or older; * who should be able to communicate properly and understand instructions. * willing and/or able to comply with the scheduled visits and other study procedures. Exclusion Criteria: * patients who already participated with their contralateral eye; * combined surgery (e.g. combined phacoemulsification and trabeculectomy); * patients with an increased risk of developing cystoid macular edema (CME) in the study eye (e.g. diabetes mellitus, previous retinal venous occlusion, or a history of uveitis, macular edema, epiretinal membrane, or previous retinal surgery); * patients who developed CME after cataract surgery in the contralateral eye; * patients with cystoid macular changes in the study eye at baseline; * patients with an increased risk of developing perioperative complications (e.g. Fuchs' endothelial dystrophy); * patients with permanent moderate visual impairment in the contralateral eye (decimal visual acuity less than 0.3); * patients with a history of steroid induced IOP rise or glaucomatous visual field loss; * patients using drugs that reduce or increase the risk of macular edema (e.g., periocular or intraocular corticosteroid, NSAID, or antivascular endothelial growth factor (VEGF) injection; topical corticosteroid or NSAID use; systemic corticosteroids (\>= 20mg prednisolon), methotrexate, biologicals, or acetazolamide), or in the previous 4 mo…

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

Change in central subfield mean macular thickness as a measurement of efficacy

Timeframe: Baseline, 6 weeks postoperatively

Trial details

NCT IDNCT05158699

SponsorLuigi Rondas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-13

View on ClinicalTrials.gov More Macular Edema trials