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

NCT ID: NCT05406973

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-12-31

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:

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.

Conditions

Refractive Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moria SBK microkeratome

Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia

Group Type: OTHER

SBK microkeratome versus femtosecond laser in flap creation

Intervention Type: DEVICE

prospective comparative non randomized interventional clinical study

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

Group Type: OTHER

SBK microkeratome versus femtosecond laser in flap creation

Intervention Type: DEVICE

prospective comparative non randomized interventional clinical study

Interventions

SBK microkeratome versus femtosecond laser in flap creation

prospective comparative non randomized interventional clinical study

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eyecare Center

OTHER

Sponsor Role: collaborator

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mona Medhat

Ophthalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yehia Salah El Din, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Ophthalmology, Kasr Al Aini

Locations

Eye Care Center

Maadi, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Kasr AlAini Hospital

Identifier Type: -

Identifier Source: org_study_id