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Search / Trial NCT06614348

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

Launched by SHANGHAI GENERAL HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Sep 24, 2024

Trial Information

Current as of July 02, 2025

Not yet recruiting

Keywords

Cataract Surgery Pain Second Eye Cataract Surgery

ClinConnect Summary

This clinical trial is looking at how well prednisolone acetate eye drops can help manage pain for patients having cataract surgery on their second eye. Cataracts are a common condition that can affect vision, and many people need surgery on both eyes. Researchers want to see if these eye drops, compared to a different type called sodium hyaluronate, can reduce pain during and after the surgery.

To participate, you need to be between 50 and 80 years old and have already had surgery on your first eye for age-related cataracts. You should be scheduled to have the second eye surgery within 30 days and should be able to cooperate with some tests before surgery. Participants will receive the eye drops two hours before their surgery and will complete a pain questionnaire afterward. It's important to note that certain health conditions and past surgeries may disqualify someone from joining the trial. If you're interested, it's a great opportunity to help improve pain management in cataract surgeries!

Gender

ALL

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.).

About Shanghai General Hospital, Shanghai Jiao Tong University School Of Medicine

Shanghai General Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, is a leading medical institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital leverages its extensive expertise in various medical specialties to conduct rigorous and ethical trials aimed at improving patient outcomes. With a focus on collaboration and scientific integrity, Shanghai General Hospital plays a pivotal role in the development of new therapies and interventions, contributing significantly to the global healthcare landscape.

Locations

Patients applied

0 patients applied

Trial Officials

Huiyi Jin

Principal Investigator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported