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

Shanghai Jiao Tong University

Status and phase

Active, not recruiting

Phase 4

Conditions

Age Related Cataract

Pain Management During Cataract Surgery

Treatments

Drug: Pranoprofen eye drops

Drug: Sodium hyaluronate eye drops

Drug: Prednisolone acetate eye drops

Study type

Interventional

Funder types

Other

Identifiers

NCT07291089

CCTR-2023C03-R

Details and patient eligibility

About

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:

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

Enrollment

126 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.