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

Walid Osama Abdel Rahman Nour El Din

Status: Completed

Conditions: Myopia, Moderate

Treatments: Procedure: FemtoLASIK; Procedure: ICL implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07291986

D261

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Simple Myopic Patients

Active Comparator group

Description:

Patients with simple myopia undergoing FemtoLASIK or ICL surgeries

Treatment:

Procedure: ICL implantation

Procedure: FemtoLASIK

Compound Myopic Patients

Active Comparator group

Description:

Patients with compound myopia undergoing FemtoLASIK or ICL surgeries

Treatment:

Procedure: ICL implantation

Procedure: FemtoLASIK