Not Yet RecruitingPhase 2

Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery

70 participantsStarted 2024-10-08

Plain-language summary

This study aims to evaluate the efficacy, safety, and potential mechanisms of prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts. Researchers will compare prednisolone acetate eye drops to sodium hyaluronate eye drops to see if prednisolone acetate eye drops work to relieve intraoperative and postoperative pain during second-eye cataract surgery. Participants will: 1. Receive prednisolone acetate eye drops or sodium hyaluronate eye drop four drops within 2 hours before cataract surgery 2. Finish cataract surgery and routine postoperative follow-up 3. Pain questionnaire completed after cataract surgery

Who can participate

Age range

50 Years – 80 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: * Age between 50-80 years old; * A clear diagnosis of age-related cataract, having completed the first eye cataract surgery at our hospital, and planning to have the second eye cataract surgery with the same doctor; * The interval between the two surgeries is ≤30 days; * Capable of cooperating to complete iris optical coherence tomography angiography examination; * Based on our team\'s previous research, a predictive scoring formula for pain during the second eye surgery has been derived (Predicted score = 1.36 + 4.93 \* preoperative iris vessel area density - 0.24 \* surgical interval (weeks)), and the calculated predicted score is \>2. Exclusion Criteria: * History of ocular trauma, ocular surgery, uveitis, fundus disease, glaucoma, or recent history of episcleritis, keratitis, severe dry eye, and other ocular surface disease episodes; * Participation in intraocular or systemic medication clinical trials within the past 6 months; * Having an autoimmune disease or currently undergoing immunosuppressive therapy; * Having a psychiatric disorder such as anxiety or depression; * History of using glucocorticoid eye drops for treatment in the second eye within the past month; * Long-term use of drugs that can cause intraoperative floppy iris syndrome, such as alpha-blockers; * Severe complications occurred during or after the first eye surgery (e.g., posterior capsule rupture, zonular exercise, nuclear drop into the vitreous cavity, postoperative endo…

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

Pain scores measured by Visual Analogue Scale

Timeframe: Within one hour after surgery

Trial details

NCT IDNCT06614348

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Huiyi Jin

021-63240090 superbaby_jin@163.com

View on ClinicalTrials.gov More Age Related Cataract trials