Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
Primary Purpose
Refractive Surgery
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
SBK microkeratome versus femtosecond laser in flap creation
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Surgery focused on measuring LASIK, SBK, femtolaser, flap creation, myopia
Eligibility Criteria
Inclusion Criteria:
- Myopes (from -1 to -9), with astigmatism up to -4, normal corneal topography, central corneal thickness (CCT) more than 500 microns, and stable refraction for at least 12 months.
Exclusion Criteria:
- CCT less than 500 microns, any ocular pathologies, one eyed patients, history of systemic disease, intraoperative complications, and abnormal corneal topography.
Sites / Locations
- Eye Care Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Moria SBK microkeratome
200-kHz Femtosecond laser system
Arm Description
Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia
Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia
Outcomes
Primary Outcome Measures
flap thickness accuracy
comparison between the accuracy of the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia, 1 month after surgery using anterior segment OCT
Secondary Outcome Measures
Visual Acuity measurment
measuring UCVA and BCVA
Full Information
NCT ID
NCT05406973
First Posted
September 13, 2017
Last Updated
March 16, 2023
Sponsor
Kasr El Aini Hospital
Collaborators
Eyecare Center
1. Study Identification
Unique Protocol Identification Number
NCT05406973
Brief Title
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
Official Title
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
Collaborators
Eyecare Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. The disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. Recent studies have shown that SBK corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.
Detailed Description
It is a prospective comparative non randomized interventional clinical study
Primary outcomes of this study include:
Comparison between the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia using anterior segment OCT (AS-OCT) 1 month after surgery in each group of patients.
Measuring corneal flap diameter using (AS-OCT)
Secondary outcomes:
Measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month postoperative.
Recording any related complications in each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Surgery
Keywords
LASIK, SBK, femtolaser, flap creation, myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moria SBK microkeratome
Arm Type
Other
Arm Description
Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia
Arm Title
200-kHz Femtosecond laser system
Arm Type
Other
Arm Description
Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia
Intervention Type
Device
Intervention Name(s)
SBK microkeratome versus femtosecond laser in flap creation
Intervention Description
prospective comparative non randomized interventional clinical study
Primary Outcome Measure Information:
Title
flap thickness accuracy
Description
comparison between the accuracy of the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia, 1 month after surgery using anterior segment OCT
Time Frame
1 month post operative
Secondary Outcome Measure Information:
Title
Visual Acuity measurment
Description
measuring UCVA and BCVA
Time Frame
1day, 1 week, 1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Myopes (from -1 to -9), with astigmatism up to -4, normal corneal topography, central corneal thickness (CCT) more than 500 microns, and stable refraction for at least 12 months.
Exclusion Criteria:
CCT less than 500 microns, any ocular pathologies, one eyed patients, history of systemic disease, intraoperative complications, and abnormal corneal topography.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehia Salah El Din, MD
Organizational Affiliation
Professor of Ophthalmology, Kasr Al Aini
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Care Center
City
Maadi
State/Province
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
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