Cytokines in Femtosecond Laser-assisted Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Other: aqueous humor collection

• Registration Number: NCT05511506
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

The investigators performed the current study to compare: 1) the pain scores by Visual Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay (ELISA); 4) the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential femtosecond laser-assisted cataract surgery (FLACS). To our knowledge, this is the first intraindividual study investigating contralateral effect in FLACS. The findings from the current study may broaden our understanding on the mechanism of sympathetic reaction, help to improve clinical performances, and provide strong clinical guidance for cataract surgeons.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-21
• Last Update Submitted: 2022-08-21
• Study First Posted: 2022-08-23
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Consecutive cataract patients aged 40-80 years, regardless of gender, with bilateral similar grades of lens opacity, and scheduled for sequential FLACS were enrolled in this study.

Exclusion Criteria

• history of ocular or systematic inflammatory diseases like uveitis, rheumatism or other autoimmune diseases;
• previous ocular surgery or trauma;
• preoperative glaucoma, zonular weakness, lens dislocation, or poor pupil dilation (measured pupil diameter <5.0 mm) or synechiae;
• use of systemic or topical steroids, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-adrenergic antagonist, or pain relief medications within 1 month prior to surgery;
• patients with baseline eye pain, having anxiety, muscle spasm around the eye or involuntary eye movement disorders which may influence the pain score;
• eyes needing for any other type of anesthesia, failed to obtain > 100 μl aqueous humor (AH) or encountered intra-operative complications like posterior capsule rupture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
second-eye group	aqueous humor collection	-
first-eye group	aqueous humor collection	-

Primary Outcome Measures

Name	Time	Method
pain scores	through study completion, an average of 1 year	pain scores of of eyes undergoing sequential FLACS by Visual Analogue Scale (VAS) scoring system, presenting as a numbered line ranging from 0 (no pain) to 10 (unbearable pain) for the severity of ever experienced pain was used. Higher scores mean a worse outcome.
cytokines concentrations	through study completion, an average of 1 year	Aqueous PGE2 concentrations were determined by using a commercially available Prostaglandin E2 Parameter ELISA Kit (USA R\&D Systems, Inc) in accordance with the manufacturer's protocol. Concentrations of 6 selected cytokines (interleukins (IL-1β, IL-1ra, IL-6, IL-8), monocyte chemotactic protein(MCP-1), tumor necrosis factor-α (TNF-α) in aqueous humor were simultaneously measured using Human Luminex Discovery Assay Multiplex Kits (USA R\&D Systems, Inc) by using methods that had been previously described.
pupil behaviors	through study completion, an average of 1 year	the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential FLACS

Trial Locations

Locations (1)

Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China; 🇨🇳 Hangzhou, China