To Compare the Clinical Outcomes of FemtoLASIK and ICL Implantation in Treating Moderate Myopia Focusing on Refractive Stability, Contrast Sensitivity and High Order Aberrations.
NCT ID: NCT07291986
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2023-01-01
2025-05-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Simple Myopic Patients
Patients with simple myopia undergoing FemtoLASIK or ICL surgeries
FemtoLASIK
FemtoLASIK surgery for simple and compound myopic patients
ICL implantation
ICL implantation for simple and compound myopic patients
Compound Myopic Patients
Patients with compound myopia undergoing FemtoLASIK or ICL surgeries
FemtoLASIK
FemtoLASIK surgery for simple and compound myopic patients
ICL implantation
ICL implantation for simple and compound myopic patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FemtoLASIK
FemtoLASIK surgery for simple and compound myopic patients
ICL implantation
ICL implantation for simple and compound myopic patients
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 media opacity.
* Patients with associated ocular pathology.
* Patients with corneal topography not fitting to either treatment modalities.
21 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Walid Osama Abdel Rahman Nour El Din
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Walid Osama Abdel Rahman Nour El Din
Cornea and Refractive Ophthalmology Consultant
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Omar M Said, MD
Role: STUDY_DIRECTOR
Faculty of Medicine, Fayoum University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Medicine, Fayoum University
Al Fayyum, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D261
Identifier Type: -
Identifier Source: org_study_id