CompletedPhase 4

Iris Vascular Area Density-Based Preoperative Pain-Risk Screening and Intervention in Second-Eye Cataract Surgery

China126 participantsStarted 2024-02-23

Plain-language summary

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

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used something called 'iris vascular area density' to predict pain risk before cataract surgery — can you explain what that measurement is, and whether it's something that was assessed before my own surgery or could be used in my care?
2Since this trial specifically looked at second-eye cataract surgery, does whatever they found about pain prediction apply to someone having their first eye done, or is the risk different depending on which eye is being operated on?
3The trial measured 'significant pain' as a score of 3 or higher on a visual analog scale during the procedure — how common is that level of intraoperative pain in your practice, and what steps do you already take to manage it?
4Because this was a Phase 4 trial, meaning it was done after the main treatments involved were already approved, does that mean the pain-screening approach they tested is something that could realistically be offered to me, or is it still considered experimental in routine cataract care?
5Now that this trial is completed, have the results changed how you think about screening patients for pain risk before cataract surgery, and is there anything in those findings I should factor into decisions about my own upcoming procedure?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants With Intraoperative Pain VAS ≥ 3 (Significant Pain)

Timeframe: Within 1 hour after surgery

Trial details

NCT IDNCT07291089

SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-20

View on ClinicalTrials.gov More Age Related Cataract trials