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OpenTrials
Completed

NCT Number: NCT07291986

To Compare the Clinical Outcomes of FemtoLASIK and ICL Implantation in Treating Moderate Myopia Focusing on Refractive Stability, Contrast Sensitivity and High Order Aberrations.

Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia.

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Key information

About this study

The clinical outcomes of FemtoLASIK and ICL implantation focusing on refractive stability, contrast sensitivity and high order aberrations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Group I - FemtoLASIK subgroup:

  • Age range: 21-40 years.
  • Stable myopia for at least one year (refractive change

≤ 0.50 D).

  • Spherical equivalent between -4.00 D and -8.00 D.
  • Corneal thickness ≥ 500 μm, residual stromal bed > 300 μm and percentage of tissue altered < 39%.
  • No evidence of keratoconus or ectatic changes on corneal topography/tomography.
  • Mesopic pupil diameter ≤ 6.5 mm.
  • Absence of ocular surface disease or significant dry eye symptoms.
  • No history of prior ocular surgery or trauma.

Group II - ICL subgroup:

  • Age range: 21-40 years.
  • Stable myopia (with or without astigmatism) for ≥1 year.
  • Spherical equivalent between -4.00 D and -8.00 D.
  • Anterior chamber depth ≥ 2.8 mm from endothelium.
  • Endothelial cell density ≥ 2500 cells/mm².
  • White-to-white and sulcus-to-sulcus diameters suitable for ICL sizing.
  • Clear crystalline lens with no signs of early cataract.
  • No history of intraocular surgery, uveitis, or glaucoma.

Exclusion criteria

Patients with mild myopia (<-4D) or high myopia (>- 8D) or hyperopia.

  • Patients with media opacity.
  • Patients with associated ocular pathology.
  • Patients with corneal topography not fitting to either treatment modalities.

Treatment and study plan

FemtoLASIK

Procedure

FemtoLASIK surgery for simple and compound myopic patients

ICL implantation

Procedure

ICL implantation for simple and compound myopic patients

Primary outcomes

  1. Refractive Stability (%)

    Time frame: From enrollment up to 6 months postoperative

    calculating the ratio between spherical equivalent postoperative to that of preoperative

  2. Contrast Sensitivity (log CS)

    Time frame: From enrollment up to 6 months postoperative

    using specialized charts and measured in logarithmic contrast sensitivity (log CS) units

  3. High Order Aberrations (μm)

    Time frame: From enrollment up to 6 months postoperative

    using the RMS value to quantify the total magnitude of wavefront deviations in the eye in micrometers

Sponsors and collaborators

Lead sponsor

Walid Osama Abdel Rahman Nour El Din

Other

Registry information

Official study title

Comparing Visual Outcomes After FemtoLasik and Implantable Collamer Lens in Treatment of Myopia

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

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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