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

September 24, 2024 updated by: Huiyi Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

A Randomized Controlled Study of Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisolone acetate eye drop group
Drug: Prednisolone acetate eye drop group
Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery
Placebo Comparator: hyaluronic acid eye drop group
Drug: Sodium hyaluronate eye drops
Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores measured by Visual Analogue Scale
Time Frame: Within one hour after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pain during the second eye surgery to the first eye surgery
Time Frame: Within one hour after surgery
Within one hour after the surgery, the investigator asks the patient to compare the pain experienced during the second eye surgery with that of the first eye surgery. The patient is asked to choose the most appropriate statement from the following: 1. I think the pain during the second eye surgery was worse than the first eye surgery; 2. I think the pain during the second eye surgery was less than the first eye surgery; 3. I think the pain during the second eye surgery was about the same as the first eye surgery; 4. I do not remember the pain during the first eye surgery; and the result is recorded by the investigator.
Within one hour after surgery
Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes
Time Frame: Within three months after surgery
The aqueous humor is detected using a cytokine array according to the instructions of manufacturer.
Within three months after surgery
Best Corrected Visual Acuity (BCVA) of the surgical eye
Time Frame: One month after surgery
When testing Best Corrected Visual Acuity (BCVA) with the Snellen chart, first ensure that the patient is wearing the appropriate corrective lenses. Then ask the patient to stand 20 feet (6 meters) away from the chart. Instruct the patient to cover one eye with a hand, and test the uncovered eye. Starting from the top, have the patient read the smallest line of text they can see clearly. Record the vision of the smallest line that the patient can read completely and correctly.
One month after surgery
Adverse events and severe adverse events
Time Frame: From enrollment to one month after surgery

Adverse Events (AEs):

Intraoperative complications: such as posterior capsule rupture, zonular dialysis, inability to implant an intraocular lens, etc.

Postoperative infection: Infection at the surgical site, which may require additional antibiotic treatment or surgical intervention.

Changes in vision: Decreased vision after surgery can occur even without apparent complications.

Elevated intraocular pressure: Intraocular pressure may be temporarily or persistently elevated after surgery, necessitating medication or surgical intervention.

Serious Adverse Events (SAEs):

Retinal detachment, endopthalmitis, persistent high intraocular pressure, severe bleeding, dislocation of the lens or intraocular lens, etc.
From enrollment to one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Huiyi Jin, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 8, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCTR-2023C03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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