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

Shanghai Jiao Tong University

Status and phase

Not yet enrolling

Phase 2

Conditions

Age Related Cataract

Pain Management During Cataract Surgery

Treatments

Drug: Sodium hyaluronate eye drops

Drug: Prednisolone acetate eye drop group

Study type

Interventional

Funder types

Other

Identifiers

NCT06614348

CCTR-2023C03

Details and patient eligibility

About

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:

Receive prednisolone acetate eye drops or sodium hyaluronate eye drop four drops within 2 hours before cataract surgery
Finish cataract surgery and routine postoperative follow-up
Pain questionnaire completed after cataract surgery

Enrollment

70 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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 endophthalmitis, glaucoma, etc.).