Conventional LASIK, Femto-LASIK and PRK in Low and Moderate MyopiaNCT06860061
Changes of Higher-Order Aberrations After Different Types of LASIK in Myopia
A study testing Laser refractive surgery in people with Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia, run by Sohag University.
Trial summary
This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Read more about this study
- Who is it for?
- Ages 18 to 45 weeks
- Conditions the study is for
- Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia
- What is being tested?
- Laser refractive surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 18 - 45 years old.
- Refraction:
- Low and moderate grades of myopia will be included:
- (According to manifest refraction) low ([0] - ≤ [-3] diopters) Moderate ([-3] - ≤ [-6] diopters) With cylinder ≤ [-1.5] diopters.
Who cannot join
- Any ocular surgery or medication, corneal opacities, pregnancy, lactation and keratoconus.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Changes of Corneal and Total Ocular Higher-Order Aberrations After Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia
This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
- Being tested
- Laser refractive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser refractive surgeryProcedure or surgery
This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
All patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination.
Corneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Conventional Lasik Receives: Procedure: Laser refractive surgery |
| group 2 | Active comparator | Femto LASIK Receives: Procedure: Laser refractive surgery |
| group 3 | Active comparator | PRK Receives: Procedure: Laser refractive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of corneal higher-order aberrations
Corneal aberrometry will be performed using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy).
Measured: 1 year
Changes of total ocular higher-order aberrations
Wavefront refraction will be acquired by the iDesign aberrometer (Hartmann-Shack Aberrometer)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conventional LASIK, Femto-LASIK and PRK in Low and Moderate MyopiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdeen Refai, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860061
- Sponsor's protocol ID
- Soh-Med-24-12-4MD
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 5 Mar 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Corneal and Total Ocular Higher-Order Aberrations After Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia
- ClinicalTrials.gov ID
- NCT06860061
- Acronym / sponsor ID
- Soh-Med-24-12-4MD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 5 Mar 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.
This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate).
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: Laser refractive surgeryConventional Lasik |
| group 2 | Active comparator | Procedure: Laser refractive surgeryFemto LASIK |
| group 3 | Active comparator | Procedure: Laser refractive surgeryPRK |
Who may qualify
- Ages
- 18 to 45 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 18 - 45 years old.
- (According to manifest refraction) low ([0] - ≤ [-3] diopters) Moderate ([-3] - ≤ [-6] diopters) With cylinder ≤ [-1.5] diopters.
Key exclusion criteria (1 listed)
- Any ocular surgery or medication, corneal opacities, pregnancy, lactation and keratoconus.
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 |
|---|---|---|
| Laser refractive surgeryThis prospective comparative interventional study will enroll patients with low and moderate myopia who seek laser vision correction at Sohag Center for LASIK and Corneal Surgeries, Sohag, Egypt. Eyes included will be divided into 3 groups according to the type of refractive surgery used (conventional LASIK, Femto-LASIK and PRK) and each group will be subdivided into 2 groups according to the degree of myopia (low and moderate). All patients will be subjected to routine comprehensive preoperative examinations including manifest uncorrected distant visual acuity (UCDVA), best corrected distant visual acuity (BCDVA), slit-lamp examination, intraocular pressure, and fundus examination. Corneal topography and corneal aberrometry will be performed on all patients using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy). The CSO topography system analyzes a total of 6144 corneal points of a corneal area within a circular annulus outlined by an inner radius of 0.33 mm and an outer | Procedure or surgery | group 1, group 2, group 3 |
Primary outcome
Changes of corneal higher-order aberrations
Time frame: 1 year
Corneal aberrometry will be performed using Sirius's Scheimpflug-Placido topography (CSO, Florence, Italy).
Changes of total ocular higher-order aberrations
Time frame: 1 year
Wavefront refraction will be acquired by the iDesign aberrometer (Hartmann-Shack Aberrometer)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Laser refractive surgery in people with Conventional LASIK, Femto-LASIK and PRK in Low and Moderate Myopia, run by Sohag University.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ahmed abdeen, Master (+201003700245, ophthabdeen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of corneal higher-order aberrations (time frame: 1 year). The study lists 2 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 5 Mar 2025.