Back to resultsCytokines in Femtosecond Laser-assisted Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aqueous humor collection
Sponsored by
About this trial
This is an interventional prevention trial for Cataract focused on measuring cataract; cytokine; pain; miosis
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
Sites / Locations
- Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
first-eye group
second-eye group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
pupil behaviors
the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential FLACS
Secondary Outcome Measures
Full Information
NCT ID
NCT05511506
First Posted
August 11, 2022
Last Updated
August 21, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05511506
Brief Title
Cytokines in Femtosecond Laser-assisted Cataract Surgery
Official Title
Comparison Between Cytokines During First and Second Eye Surgeries in Patients With Bilateral Femtosecond Laser-assisted Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract; cytokine; pain; miosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
first-eye group
Arm Type
Other
Arm Title
second-eye group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
aqueous humor collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain scores
Description
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.
Time Frame
through study completion, an average of 1 year
Title
cytokines concentrations
Description
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.
Time Frame
through study completion, an average of 1 year
Title
pupil behaviors
Description
the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential FLACS
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yu yinhui, MD
Organizational Affiliation
Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
City
Hangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
Cytokines in Femtosecond Laser-assisted Cataract Surgery
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