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

December 5, 2025 updated by: Walid Osama Abdel Rahman Nour El Din

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Fayyum, Egypt
        • Faculty of medicine, Fayoum university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Simple Myopic Patients
Patients with simple myopia undergoing FemtoLASIK or ICL surgeries
Procedure: FemtoLASIK
FemtoLASIK surgery for simple and compound myopic patients
Procedure: ICL implantation
ICL implantation for simple and compound myopic patients
Active Comparator: Compound Myopic Patients
Patients with compound myopia undergoing FemtoLASIK or ICL surgeries
Procedure: FemtoLASIK
FemtoLASIK surgery for simple and compound myopic patients
Procedure: ICL implantation
ICL implantation for simple and compound myopic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refractive Stability (%)
Time Frame: From enrollment up to 6 months postoperative
calculating the ratio between spherical equivalent postoperative to that of preoperative
From enrollment up to 6 months postoperative
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
From enrollment up to 6 months postoperative
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
From enrollment up to 6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walid Osama Abdel Rahman Nour El Din

Investigators

  • Study Director: Omar M Said, MD, Faculty of medicine, Fayoum university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

May 6, 2025

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D261

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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