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

NCT06614348 | Not Yet Recruiting Phase 2

• 1 other identifier: CCTR-2023C03
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Age Related Cataract; Pain Management During Cataract Surgery

Keywords

cataract surgery; pain; second-eye cataract surgery

Outcome Measures

Primary Outcomes (1)

• Pain scores measured by Visual Analogue Scale

  Within one hour after surgery, the investigator uses the Visual Analogue Scale (VAS) to allow the patient to self-assess the degree of pain. A movable ruler about 10 cm long is used, with one side unmarked and the other side marked with scales, with the ends labeled "0" for no pain and "10" for the most severe pain that is unbearable. The investigator holds the marked side of the ruler away from the patient, allowing the patient to mark the position on the ruler that represents their level of pain. The investigator then records the corresponding score based on the position marked by the patient.

  Within one hour after surgery

Secondary Outcomes (4)

• Comparison of pain during the second eye surgery to the first eye surgery

  Within one hour after surgery

• Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes

  Within three months after surgery

• Best Corrected Visual Acuity (BCVA) of the surgical eye

  One month after surgery

• Adverse events and severe adverse events

  From enrollment to one month after surgery

Study Arms (2)

Prednisolone acetate eye drop group

EXPERIMENTAL

Drug: Prednisolone acetate eye drop group

hyaluronic acid eye drop group

PLACEBO COMPARATOR

Drug: Sodium hyaluronate eye drops

Interventions

Prednisolone acetate eye drop group DRUG

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

Prednisolone acetate eye drop group

Sodium hyaluronate eye drops DRUG

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

hyaluronic acid eye drop group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Related Publications (2)

• 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.

  PMID: 30065652 BACKGROUND

• 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.

  PMID: 37350758 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huiyi Jin

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiyi Jin

CONTACT

021-63240090; superbaby_jin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Chief Physician,

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: October 8, 2024
• Primary Completion: June 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09