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: 1. 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) 2. Undergo cataract surgery and routine postoperative follow-up 3. Within 1 hour after surgery, provide a pain visual analog scale (VAS) score under the guidance of the investigator
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
126
Participants receive one drop of pranoprofen instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery.
Participants receive one drop of prednisolone acetate instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery.
Participants receive one drop of sodium hyaluronate instilled into the operative eye at 2 hours, 1.5 hours, 1 hour, and 30 minutes before cataract surgery.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Proportion of Participants With Intraoperative Pain VAS ≥ 2 (Significant Pain)
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 ≥ 2.
Time frame: Within 1 hour after surgery
Intraoperative Pain VAS Score
VAS score on a 0-10 scale, obtained with the same standardized method as the primary outcome.
Time frame: Within 1 hour after surgery
Patient-Reported Comparison of Second-Eye vs First-Eye Intraoperative Pain
Within 1 hour after surgery, participants are asked to select one statement that best describes how pain during the second-eye surgery compares with their first-eye experience: 1. "More painful than the first eye"; 2. "Less painful than the first eye"; 3. "About the same as the first eye"; 4. "I do not remember the pain during the first eye." The selected response is recorded.
Time frame: Within 1 hour after surgery
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