Preoperative Pain-Risk Screening and Intervention for Intraoperative Pain in Second-Eye Cataract Surgery Based on Iris Vascular Area Density
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Intraoperative Pain VAS ≥ 3 (Significant Pain)
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of pranoprofen or prednisolone acetate eye drops for pain management in patients undergoing second-eye surgery for age-related cataracts. Researchers will compare pranoprofen or prednisolone acetate eye drops with sodium hyaluronate eye drops to determine whether pranoprofen or prednisolone acetate eye drops can relieve intraoperative pain during second-eye cataract surgery.
Participants will:
- Receive one drop in the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery (pranoprofen, prednisolone acetate, or sodium hyaluronate)
- Undergo cataract surgery and routine postoperative follow-up
- Within 1 hour after surgery, provide a pain visual analog scale (VAS) score under the guidance of the investigator
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 50 years.
- •Definite diagnosis of age-related cataract.
- •The first-eye cataract surgery under local anesthesia has been completed at this hospital, and the second-eye cataract surgery under local anesthesia is planned with the same surgeon within 1 year of the first-eye surgery.
- •Able to cooperate with preoperative iris optical coherence tomography angiography (OCTA) examination of the operative eye.
- •On the day of the second-eye surgery, preoperative iris vascular area density (VAD) ≥ 0.2167 in the operative eye.
排除标准
- •History of ocular trauma, ocular surgery (excluding the first-eye cataract surgery already performed), uveitis, chorioretinal disease, glaucoma;
- •Presence of significant corneal disease, marked iris abnormalities, or any active ocular surface disease, including recent conjunctivitis, keratitis, or severe dry eye.
- •Severe complications during or after the first-eye surgery (e.g., posterior capsule rupture, zonular dialysis, dislocation of the lens nucleus into the vitreous cavity, postoperative endophthalmitis, or glaucoma).
- •History of chronic pain syndromes or neuropathic pain.
- •Long-term use of opioids, other systemic analgesics, or sedative-hypnotic drugs.
- •Known autoimmune disease or ongoing immunosuppressive therapy.
- •Severe psychiatric disorders or cognitive impairment interfering with pain assessment.
- •Use of topical corticosteroid eye drops in the second eye within 1 month prior to the planned surgery.
- •Long-term use of α-adrenergic blockers or other medications associated with intraoperative floppy iris syndrome (IFIS).
- •Participation in any other clinical trial involving ophthalmic or systemic drugs within the past 6 months.
- •Known allergy or contraindication to topical nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., pranoprofen) or topical corticosteroids (e.g., prednisolone acetate) used in this study.
研究组 & 干预措施
Pranoprofen ophthalmic solution group
干预措施: Pranoprofen eye drops (Drug)
Prednisolone acetate ophthalmic suspension group
干预措施: Prednisolone acetate eye drops (Drug)
Sodium hyaluronate ophthalmic solution group
干预措施: Sodium hyaluronate eye drops (Drug)
结局指标
主要结局
Proportion of Participants With Intraoperative Pain VAS ≥ 3 (Significant Pain)
时间窗: Within 1 hour after surgery
Intraoperative pain is assessed within 1 hour after surgery using a 0-10 visual analog scale (VAS; 0 = no pain, 10 = most severe pain). The investigator presents the unmarked side to the participant to mark perceived intraoperative pain; the investigator reads the corresponding value on the marked reverse side and records the score. The primary endpoint is the proportion of participants with VAS ≥ 3.
次要结局
- Intraoperative Pain VAS Score(Within 1 hour after surgery)
- Patient-Reported Comparison of Second-Eye vs First-Eye Intraoperative Pain(Within 1 hour after surgery)
研究者
Huiyi Jin
Principal Investigator, Associate Chief Physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine