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Completed

NCT Number: NCT07291089

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Pranoprofen eye drops

Drug

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.

Prednisolone acetate eye drops

Drug

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.

Sodium hyaluronate eye drops

Drug

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.

Primary outcomes

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

    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.

Secondary outcomes

  1. Intraoperative Pain VAS Score

    Time frame: Within 1 hour after surgery

    VAS score on a 0-10 scale, obtained with the same standardized method as the primary outcome.

  2. Patient-Reported Comparison of Second-Eye vs First-Eye Intraoperative Pain

    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:

    • "More painful than the first eye";
    • "Less painful than the first eye";
    • "About the same as the first eye";
    • "I do not remember the pain during the first eye." The selected response is recorded.

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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