Cytokines in Femtosecond Laser-assisted Cataract Surgery

NCT05511506 | Completed

• 1 other identifier: 2022-0473
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

cataract; cytokine; pain; miosis

Outcome Measures

Primary Outcomes (3)

• pain scores

  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.

  through study completion, an average of 1 year

• cytokines concentrations

  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.

  through study completion, an average of 1 year

• pupil behaviors

  the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential FLACS

  through study completion, an average of 1 year

Study Arms (2)

first-eye group

OTHER

Other: aqueous humor collection

second-eye group

OTHER

Other: aqueous humor collection

Interventions

aqueous humor collection OTHER

Once the laser procedures were finished, the patient was transported to another surgery operating bed. Before the eyeball was opened, 100-200 μL of aqueous humor was obtained from the anterior chamber via an ultra-thin needle through the paracentesis site of cornea.

first-eye group; second-eye group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China

Hangzhou, China

Location

MeSH Terms

Conditions

Cataract; Pain; Miosis

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pupil Disorders; Nervous System Diseases

Study Officials

• yu yinhui, MD

  Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 23, 2022
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-01

Locations

CN (1)