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Completed

NCT Number: NCT05406973

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.

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Key information

Conditions

Refractive Surgery Eye Diseases Myopia Refractive Errors

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Care Center

Maadi, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SBK microkeratome versus femtosecond laser in flap creation

Device

prospective comparative non randomized interventional clinical study

Primary outcomes

  1. flap thickness accuracy

    Time frame: 1 month post operative

    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 outcomes

  1. Visual Acuity measurment

    Time frame: 1day, 1 week, 1 month after surgery

    measuring UCVA and BCVA

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Collaborators

  • Eyecare Center

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2022
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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