Myopia, ModerateNCT07291986
To Compare the Clinical Outcomes of FemtoLASIK and ICL Implantation in Treating Moderate Myopia Focusing on Refractive Stability, Contrast Sensitivity and High Order Aberrations.
A study testing FemtoLASIK and ICL implantation in people with Myopia, Moderate, run by Walid Osama Abdel Rahman Nour El Din at 1 site in Egypt.
Trial summary
Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Moderate
- What is being tested?
- FemtoLASIK and ICL implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 6 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%.
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Visual Outcomes After FemtoLasik and Implantable Collamer Lens in Treatment of Myopia
Compare the clinical outcomes of FemtoLASIK and ICL implantation in treating moderate myopia.
Read the detailed description
The clinical outcomes of FemtoLASIK and ICL implantation focusing on refractive stability, contrast sensitivity and high order aberrations.
- Conditions
- Myopia, Moderate
- Being tested
- FemtoLASIK, ICL implantation
- Keywords
- FemtoLASIK, ICL, myopia, HOA, contrast sensitivity
- Medical subject headings
- Myopia, Lymphoma, Follicular, T-Lymphocytopenia, Idiopathic CD4-Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemtoLASIKProcedure or surgery
FemtoLASIK surgery for simple and compound myopic patients
ICL implantationProcedure or surgery
ICL implantation for simple and compound myopic patients
| Study group | Role | What they receive |
|---|---|---|
| Simple Myopic Patients | Active comparator | Patients with simple myopia undergoing FemtoLASIK or ICL surgeries Receives: Procedure: FemtoLASIK; Procedure: ICL implantation |
| Compound Myopic Patients | Active comparator | Patients with compound myopia undergoing FemtoLASIK or ICL surgeries Receives: Procedure: FemtoLASIK; Procedure: ICL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Stability (%)
calculating the ratio between spherical equivalent postoperative to that of preoperative
Measured: From enrollment up to 6 months postoperative
Contrast Sensitivity (log CS)
using specialized charts and measured in logarithmic contrast sensitivity (log CS) units
Measured: 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
Measured: From enrollment up to 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid Osama Abdel Rahman Nour El Din
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Walid Osama Abdel Rahman Nour El Din, Fayoum University
- Investigators
- Omar M Said, MD, Study director, Faculty of Medicine, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291986
- Sponsor's protocol ID
- D261
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Visual Outcomes After FemtoLasik and Implantable Collamer Lens in Treatment of Myopia
- ClinicalTrials.gov ID
- NCT07291986
- Acronym / sponsor ID
- D261
- Conditions
- Myopia, Moderate
- Keywords
- FemtoLASIK, ICL, myopia, HOA, contrast sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Walid Osama Abdel Rahman Nour El DinUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple Myopic Patients | Active comparator | Procedure: FemtoLASIK, Procedure: ICL implantationPatients with simple myopia undergoing FemtoLASIK or ICL surgeries |
| Compound Myopic Patients | Active comparator | Procedure: FemtoLASIK, Procedure: ICL implantationPatients with compound myopia undergoing FemtoLASIK or ICL surgeries |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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%.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FemtoLASIKFemtoLASIK surgery for simple and compound myopic patients | Procedure or surgery | Compound Myopic Patients, Simple Myopic Patients |
| ICL implantationICL implantation for simple and compound myopic patients | Procedure or surgery | Compound Myopic Patients, Simple Myopic Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar M Said, MD study director
Faculty of Medicine, Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FemtoLASIK and ICL implantation in people with Myopia, Moderate, run by Walid Osama Abdel Rahman Nour El Din at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Stability (%) (time frame: From enrollment up to 6 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.