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

NCT07291986 | Completed

• 1 other identifier: D261
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia, Moderate

Keywords

FemtoLASIK, ICL, myopia, HOA, contrast sensitivity

Outcome Measures

Primary Outcomes (3)

• Refractive Stability (%)

  calculating the ratio between spherical equivalent postoperative to that of preoperative

  From enrollment up to 6 months postoperative

• Contrast Sensitivity (log CS)

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

  From enrollment up to 6 months postoperative

• High Order Aberrations (μm)

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

  From enrollment up to 6 months postoperative

Study Arms (2)

Simple Myopic Patients

ACTIVE COMPARATOR

Patients with simple myopia undergoing FemtoLASIK or ICL surgeries

Procedure: FemtoLASIK; Procedure: ICL implantation

Compound Myopic Patients

ACTIVE COMPARATOR

Patients with compound myopia undergoing FemtoLASIK or ICL surgeries

Procedure: FemtoLASIK; Procedure: ICL implantation

Interventions

FemtoLASIK PROCEDURE

FemtoLASIK surgery for simple and compound myopic patients

Compound Myopic Patients; Simple Myopic Patients

ICL implantation PROCEDURE

ICL implantation for simple and compound myopic patients

Compound Myopic Patients; Simple Myopic Patients

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walid Osama Abdel Rahman Nour El Din: lead

Study Sites (1)

Faculty of Medicine, Fayoum University

Al Fayyum, Egypt

Location

MeSH Terms

Conditions

Myopia; Lymphoma, Follicular; T-Lymphocytopenia, Idiopathic CD4-Positive

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphopenia; Leukopenia; Cytopenia; Hematologic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes

Study Officials

• Omar M Said, MD

  Faculty of Medicine, Fayoum University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cornea and Refractive Ophthalmology Consultant

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: May 6, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

EG (1)