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

NCT07291089 | Completed Phase 4

• 1 other identifier: CCTR-2023C03-R
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Undergo cataract surgery and routine postoperative follow-up
3. 3.Within 1 hour after surgery, provide a pain visual analog scale (VAS) score under the guidance of the investigator

Conditions

Age Related Cataract; Pain Management During Cataract Surgery

Keywords

Cataract surgery; Pain; Second-eye cataract surgery

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Intraoperative Pain VAS ≥ 3 (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 ≥ 3.

  Within 1 hour after surgery

Secondary Outcomes (2)

• 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

Study Arms (3)

Pranoprofen ophthalmic solution group

EXPERIMENTAL

Drug: Pranoprofen eye drops

Prednisolone acetate ophthalmic suspension group

EXPERIMENTAL

Drug: Prednisolone acetate eye drops

Sodium hyaluronate ophthalmic solution group

PLACEBO COMPARATOR

Drug: Sodium hyaluronate eye drops

Interventions

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.

Pranoprofen ophthalmic solution group

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.

Prednisolone acetate ophthalmic suspension group

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.

Sodium hyaluronate ophthalmic solution group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (3)

• Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.

  PMID: 26305528 BACKGROUND

• Zhang Y, Du Y, Jiang Y, Zhu X, Lu Y. Effects of Pranoprofen on Aqueous Humor Monocyte Chemoattractant Protein-1 Level and Pain Relief During Second-Eye Cataract Surgery. Front Pharmacol. 2018 Jul 17;9:783. doi: 10.3389/fphar.2018.00783. eCollection 2018.

  PMID: 30065652 BACKGROUND

• Cui L, Ma Y, Wang Y, Luo Q, Ding Q, Ge L, Lu S, Miao Y, Sun Q, Zou H, Jin H. Combination of iris vessel area density and surgery interval as the predictor of perceived pain during consecutive second-eye cataract surgery. J Cataract Refract Surg. 2023 Aug 1;49(8):858-863. doi: 10.1097/j.jcrs.0000000000001229.

  PMID: 37350758 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Chief Physician

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: February 23, 2024
• Primary Completion: November 20, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CN (1)