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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Prednisolone acetate eye drop group
  Patients receive prednisolone acetate eye drops 4 times per 30min within 2 hours before cataract surgery
• Препарат Sodium hyaluronate eye drops
  Patients receive sodium hyaluronate eye drops 4 times per 30min within 2 hours before cataract surgery

Первичные конечные точки

• Pain scores measured by Visual Analogue Scale [Срок оценки: Within one hour after surgery]

Вторичные конечные точки (4)

• Comparison of pain during the second eye surgery to the first eye surgery [Срок оценки: Within one hour after surgery]
• Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes [Срок оценки: Within three months after surgery]
• Best Corrected Visual Acuity (BCVA) of the surgical eye [Срок оценки: One month after surgery]
• Adverse events and severe adverse events [Срок оценки: From enrollment to one month after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06614348 · CCTR-2023C03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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