A Randomized Controlled Study of Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Pain scores measured by Visual Analogue Scale
研究概览
简要总结
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:
- Receive prednisolone acetate eye drops or sodium hyaluronate eye drop four drops within 2 hours before cataract surgery
- Finish cataract surgery and routine postoperative follow-up
- Pain questionnaire completed after cataract surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
研究组 & 干预措施
Prednisolone acetate eye drop group
干预措施: Prednisolone acetate eye drop group (Drug)
hyaluronic acid eye drop group
干预措施: Sodium hyaluronate eye drops (Drug)
结局指标
主要结局
Pain scores measured by Visual Analogue Scale
时间窗: 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.
次要结局
- Comparison of pain during the second eye surgery to the first eye surgery(Within one hour after surgery)
- Expression levels of monocyte chemotactic protein-1 in the aqueous humor of surgical eyes(Within three months after surgery)
- Best Corrected Visual Acuity (BCVA) of the surgical eye(One month after surgery)
- Adverse events and severe adverse events(From enrollment to one month after surgery)
研究者
Huiyi Jin
Principal Investigator, Associate Chief Physician,
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine