Clinical trial NCT06614348: Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
Official title: A Randomized Controlled Study of Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Age Related Cataract
Pain Management During Cataract Surgery
Keywords: cataract surgery
pain
second-eye cataract surgery
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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\&#39;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 \&gt;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.).

Primary outcomes:
measure: Pain scores measured by Visual Analogue Scale
timeFrame: Within one hour after surgery
Secondary outcomes:
measure: Comparison of pain during the second eye surgery to the first eye surgery
timeFrame: Within one hour after surgery
measure: Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes
timeFrame: Within three months after surgery
measure: Best Corrected Visual Acuity (BCVA) of the surgical eye
timeFrame: One month after surgery
measure: Adverse events and severe adverse events
timeFrame: From enrollment to one month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Huiyi Jin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.