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

NCT ID: NCT06614348

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-11-30

Brief 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

Conditions

Age Related Cataract; Pain Management During Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Prednisolone acetate eye drop group

Group Type: EXPERIMENTAL

Prednisolone acetate eye drop group

Intervention Type: DRUG

Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery

hyaluronic acid eye drop group

Group Type: PLACEBO_COMPARATOR

Sodium hyaluronate eye drops

Intervention Type: DRUG

Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery

Interventions

Prednisolone acetate eye drop group

Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery

Intervention Type: DRUG

Sodium hyaluronate eye drops

Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery

Intervention Type: DRUG

Eligibility Criteria

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.).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Huiyi Jin

Principal Investigator, Associate Chief Physician,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huiyi Jin

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Central Contacts

Huiyi Jin

Role: CONTACT

superbaby_jin@163.com

021-63240090

References

Zhang Y, Du Y, Jiang Y, Zhu X, Lu Y. Effects of Pranoprofen on Aqueous Humor Monocyte Chemoattractant Protein-1 Level and Pain Relief During Second-Eye Cataract Surgery. Front Pharmacol. 2018 Jul 17;9:783. doi: 10.3389/fphar.2018.00783. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30065652 (View on PubMed)

Cui L, Ma Y, Wang Y, Luo Q, Ding Q, Ge L, Lu S, Miao Y, Sun Q, Zou H, Jin H. Combination of iris vessel area density and surgery interval as the predictor of perceived pain during consecutive second-eye cataract surgery. J Cataract Refract Surg. 2023 Aug 1;49(8):858-863. doi: 10.1097/j.jcrs.0000000000001229.

Reference Type: BACKGROUND

PMID: 37350758 (View on PubMed)

Other Identifiers

CCTR-2023C03

Identifier Type: -

Identifier Source: org_study_id