Cytokines in Femtosecond Laser-assisted Cataract Surgery

Cataract Clinical Trial

Official title:

Comparison Between Cytokines During First and Second Eye Surgeries in Patients With Bilateral Femtosecond Laser-assisted Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511506
• Other study ID #: 2022-0473
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• aqueous humor collection
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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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-1ß, IL-1ra, IL-6, IL-8), monocyte chemotactic protein(MCP-1), tumor necrosis factor-a (TNF-a) 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
Primary	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