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Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia.
The clinical outcomes of FemtoLASIK and ICL implantation focusing on refractive stability, contrast sensitivity and high order aberrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple Myopic Patients | Active Comparator | Patients with simple myopia undergoing FemtoLASIK or ICL surgeries |
|
| Compound Myopic Patients | Active Comparator | Patients with compound myopia undergoing FemtoLASIK or ICL surgeries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FemtoLASIK | Procedure | FemtoLASIK surgery for simple and compound myopic patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Exclusion Criteria:
Patients with mild myopia (<-4D) or high myopia (>- 8D) or hyperopia.
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| Name | Affiliation | Role |
|---|---|---|
| Omar M Said, MD | Faculty of Medicine, Fayoum University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Fayoum University | Al Fayyum | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2021 |
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| ICL implantation | Procedure | ICL implantation for simple and compound myopic patients |
|
| Dec 5, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D008224 | Lymphoma, Follicular |
| D018344 | T-Lymphocytopenia, Idiopathic CD4-Positive |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008231 | Lymphopenia |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D007960 | Leukocyte Disorders |
| D007153 | Immunologic Deficiency Syndromes |
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