Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia

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.

Study Overview

• Status: Completed
• Conditions: Refractive Surgery
• Intervention / Treatment: Device: SBK microkeratome versus femtosecond laser in flap creation

Detailed Description

It is a prospective comparative non randomized interventional clinical study

Primary outcomes of this study include:

1. 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.
2. Measuring corneal flap diameter using (AS-OCT)

Secondary outcomes:

1. Measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month postoperative.
2. Recording any related complications in each group.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Maadi, Cairo, Egypt
      • Eye Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Moria SBK microkeratome; Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia	Device: SBK microkeratome versus femtosecond laser in flap creation; prospective comparative non randomized interventional clinical study
Other: 200-kHz Femtosecond laser system; Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia	Device: SBK microkeratome versus femtosecond laser in flap creation; prospective comparative non randomized interventional clinical study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity measurment	measuring UCVA and BCVA	1day, 1 week, 1 month after surgery

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Collaborators: Eyecare Center
• Investigators: Principal Investigator: Yehia Salah El Din, MD, Professor of Ophthalmology, Kasr Al Aini

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: June 4, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: LASIK, SBK, femtolaser, flap creation, myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: Kasr AlAini Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No