Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080, China
NCT Number: NCT07291089
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
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 4
Shanghai, Shanghai Municipality, 200080, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Within 1 hour after surgery
VAS score on a 0-10 scale, obtained with the same standardized method as the primary outcome.
Time frame: Within 1 hour after surgery
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:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
Preoperative Pain-Risk Screening and Intervention for Intraoperative Pain in Second-Eye Cataract Surgery Based on Iris Vascular Area Density
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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