To Compare the Clinical Outcomes of FemtoLASIK and ICL Implantation in Treating Moderate Myopia F… (NCT07291986) | Clinical Trial Compass
CompletedNot Applicable
To Compare the Clinical Outcomes of FemtoLASIK and ICL Implantation in Treating Moderate Myopia Focusing on Refractive Stability, Contrast Sensitivity and High Order Aberrations.
Egypt60 participantsStarted 2023-01-01
Plain-language summary
Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia.
Who can participate
Age range21 Years – 40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Refractive Stability (%)
Timeframe: From enrollment up to 6 months postoperative
2
Contrast Sensitivity (log CS)
Timeframe: From enrollment up to 6 months postoperative
3
High Order Aberrations (μm)
Timeframe: From enrollment up to 6 months postoperative