Status Approved
First Submitted Date
2020/12/14
Registered Date
2020/12/29
Last Updated Date
2020/12/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005717 |
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Unique Protocol ID | 2020-0056 |
Public/Brief Title | inflammation and medication in femtosecond laser-assisted cataract surgery |
Scientific Title | Effect of Preoperative Eyedrops on Cytokine Concentrations in Aqueous Humor of Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery |
Acronym | anti-inflammatory eyedrops for femtosecond laser-assisted cataract surgery |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-0056 |
Approval Date | 2020-01-17 |
Institutional Review Board Name | Institutional Review Board of the Asan Medical Center and the University of Ulsan College of Medicine |
Institutional Review Board Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Institutional Review Board Telephone | 02-3010-7166 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Hungwon Tchah |
Title | Dr |
Telephone | +82-2-3010-3680 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Contact Person for Public Queries | |
Name | Hungwon Tchah |
Title | Dr |
Telephone | +82-2-3010-3680 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
Contact Person for Updating Information | |
Name | Hungwon Tchah |
Title | Dr |
Telephone | +82-2-3010-3680 |
Affiliation | Asan Medical Center |
Address | 88, Olympic-ro 43-gil, Songpa-gu, Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2020-01-17 Actual | |
Target Number of Participant | 120 | |
Primary Completion Date | 2021-12-31 , Anticipated | |
Study Completion Date | 2021-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Asan Medical Center | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2020-01-17 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
Project ID | 2020-0056 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | The number of patients undergoing femtosecond laser-assiated cataract surgery is increasing, however, the intraocular effects of it have not been sufficiently evaluated. The purpose of this study was to compare the anti-inflammatory activity of preoperatively applied eyedrops, as determined by cytokine concentrations in aqueous humor collected during surgery in patients undergoing femtosecond laser-assisted cataract surgery. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | A total of 120 patients undergoing femtosecond laser-assisted cataract surgery were randomly assigned to four groups of 30 patients each who were administered no eyedrops, fluorometholone 0.1% (Flumetholone®) eyedrops, ketorolac tromethamine 0.45% (ACUVAIL®) eyedrops, and both 0.1% fluorometholone and 0.45% ketorolac tromethamine. Eyedrops were instilled 1 hour, 20 minutes, and just before surgery. After femtosecond laser surgery, a corneal incision of about 1 mm was made in the 2 o'clock position, and about 0.1 cc aqueous humor was obtained using a 1 cc syringe and a 26-gauge needle. Cytokine and PGE2 concentrations were quantitatively determined. |
Number of Arms | 4 |
Arm 1 |
Arm Label control group |
Target Number of Participant 30 |
|
Arm Type No intervention |
|
Arm Description the group who were administered no eyedrops |
|
Arm 2 |
Arm Label steroid group |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description the group who were administered a drop of Fluorometholone 0.1% (Flumetholone®) eyedrops three times preoperatively |
|
Arm 3 |
Arm Label NSAID group |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description the group who were administered a drop of Ketorolac tromethamine 0.45% (Acuvail®) eyedrops three times preoperatively |
|
Arm 4 |
Arm Label steroid plus NSAID group |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description the group who were administered both a drop of Fluorometholone 0.1% (Flumetholone®) and Ketorolac tromethamine 0.45% (Acuvail®) eyedrops three times preoperatively |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (H00-H59)Diseases of the eye and adnexa (H26.99)Cataract, unspecified, unspecified side cataract |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 21Year~80Year |
|
Description patients with uncomplicated senile cataract undergoing unilateral femtosecond laser-assited cataract surgery |
|
Exclusion Criteria |
patients with history of ocular surgery or trauma, corneal opacity, retinopathy, glaucoma, uveitis, amblyopia or complication including intraoperative posterior capsule rupture |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | IL-6 concentration in aqueous humor |
|
Timepoint | right after the femtosecond laser |
|
Primary Outcome(s) 2 | ||
Outcome | IL-8 concentration in aqueous humor |
|
Timepoint | right after the femtosecond laser |
|
Primary Outcome(s) 3 | ||
Outcome | TNF-α concentration in aqueous humor |
|
Timepoint | right after the femtosecond laser |
|
Primary Outcome(s) 4 | ||
Outcome | PGE2 concentration in aqueous humor |
|
Timepoint | right after the femtosecond laser |
|
Secondary Outcome(s) 1 | ||
Outcome | age |
|
Timepoint | enroll |
|
Secondary Outcome(s) 2 | ||
Outcome | gender |
|
Timepoint | enroll |
|
Secondary Outcome(s) 3 | ||
Outcome | Eye laterality |
|
Timepoint | enroll |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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