Cytokines in Femtosecond Laser-assisted Cataract Surgery

NCT ID: NCT05511506

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

first-eye group

Group Type: OTHER

aqueous humor collection

Intervention Type: 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.

second-eye group

Group Type: OTHER

aqueous humor collection

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yu yinhui, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hangzhou, , China

Countries

China

Other Identifiers

2022-0473

Identifier Type: -

Identifier Source: org_study_id