Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisolone acetate eye drop group, Sodium hyaluronate eye drops.
- Who it may be relevant to
- Registry conditions: Age Related Cataract, Pain Management During Cataract Surgery. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Study of Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
Overview
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
Interventions
- Drug Prednisolone acetate eye drop group
Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery - Drug Sodium hyaluronate eye drops
Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery
Primary outcome measures
- Pain scores measured by Visual Analogue Scale [Time frame: Within one hour after surgery]
Secondary outcome measures (4)
- Comparison of pain during the second eye surgery to the first eye surgery [Time frame: 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]
- Best Corrected Visual Acuity (BCVA) of the surgical eye [Time frame: One month after surgery]
- Adverse events and severe adverse events [Time frame: From enrollment to one month after surgery]
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
Identifiers
NCT: NCT06614348 · CCTR-2023C03