Iris Vascular Area Density-Based Preoperative Pain-Risk Screening and Intervention in Second-Eye Cataract Surgery
NCT ID: NCT07291089
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
126 participants
INTERVENTIONAL
2024-02-23
2025-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pranoprofen ophthalmic solution group
Pranoprofen eye drops
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 ophthalmic suspension group
Prednisolone acetate eye drops
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 ophthalmic solution group
Sodium hyaluronate eye drops
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.
Interventions
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Pranoprofen eye drops
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Huiyi Jin
Principal Investigator, Associate Chief Physician
Locations
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
Other Identifiers
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CCTR-2023C03-R
Identifier Type: -
Identifier Source: org_study_id