Comparing Visual Outcomes After FemtoLasik and Implantable Collamer Lens in Treatment of Myopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Refractive Stability (%)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Group I - FemtoLASIK subgroup:
- •Age range: 21-40 years.
- •Stable myopia for at least one year (refractive change
- •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.
Outcomes
Primary Outcomes
Refractive Stability (%)
Time Frame: From enrollment up to 6 months postoperative
calculating the ratio between spherical equivalent postoperative to that of preoperative
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Walid Osama Abdel Rahman Nour El Din
Cornea and Refractive Ophthalmology Consultant
Fayoum University