Myopia, Moderate
Conditions
Keywords
FemtoLASIK, ICL, myopia, HOA, contrast sensitivity
Brief summary
Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia.
Detailed description
The clinical outcomes of FemtoLASIK and ICL implantation focusing on refractive stability, contrast sensitivity and high order aberrations.
Interventions
PROCEDUREFemtoLASIK
FemtoLASIK surgery for simple and compound myopic patients
PROCEDUREICL implantation
ICL implantation for simple and compound myopic patients
Sponsors
Walid Osama Abdel Rahman Nour El Din
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Refractive Stability (%) | From enrollment up to 6 months postoperative | calculating the ratio between spherical equivalent postoperative to that of preoperative |
| Contrast Sensitivity (log CS) | From enrollment up to 6 months postoperative | using specialized charts and measured in logarithmic contrast sensitivity (log CS) units |
| High Order Aberrations (μm) | From enrollment up to 6 months postoperative | using the RMS value to quantify the total magnitude of wavefront deviations in the eye in micrometers |
Countries
Egypt
Outcome results
None listed