Refractive SurgeryNCT05406973
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
A study testing SBK microkeratome versus femtosecond laser in flap creation in people with Refractive Surgery, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Surgery
- What is being tested?
- SBK microkeratome versus femtosecond laser in flap creation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 31 Dec 2021
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Myopes (from -1 to -9), with astigmatism up to -4, normal corneal topography, central corneal thickness (CCT) more than 500 microns, and stable refraction for at least 12 months.
Who cannot join
- CCT less than 500 microns, any ocular pathologies, one eyed patients, history of systemic disease, intraoperative complications, and abnormal corneal topography.
Trial locations and contacts
1 site in 1 country.
About this study
LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. The disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. Recent studies have shown that SBK corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.
Read the detailed description
It is a prospective comparative non randomized interventional clinical study
Primary outcomes of this study include:
- Comparison between the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia using anterior segment OCT (AS-OCT) 1 month after surgery in each group of patients.
- Measuring corneal flap diameter using (AS-OCT)
Secondary outcomes:
- Measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month postoperative.
- Recording any related complications in each group.
- Conditions
- Refractive Surgery
- Being tested
- SBK microkeratome versus femtosecond laser in flap creation
- Keywords
- LASIK, SBK, femtolaser, flap creation, myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBK microkeratome versus femtosecond laser in flap creationDevice
prospective comparative non randomized interventional clinical study
| Study group | Role | What they receive |
|---|---|---|
| Moria SBK microkeratome | Other | Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia Receives: Device: SBK microkeratome versus femtosecond laser in flap creation |
| 200-kHz Femtosecond laser system | Other | Comparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia Receives: Device: SBK microkeratome versus femtosecond laser in flap creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
flap thickness accuracy
comparison between the accuracy of the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia, 1 month after surgery using anterior segment OCT
Measured: 1 month post operative
Secondary outcomes (1)
Visual Acuity measurment
measuring UCVA and BCVA
Measured: 1day, 1 week, 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive SurgeryStudies 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
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eyecare Center
- Responsible party
- Principal investigator, Mona Medhat, Kasr El Aini Hospital
- Investigators
- Yehia Salah El Din, MD, Principal investigator, Professor of Ophthalmology, Kasr Al Aini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406973
- Sponsor's protocol ID
- Kasr AlAini Hospital
- Status last verified
- Mar 2023
- First submitted
- 13 Sep 2017
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
- ClinicalTrials.gov ID
- NCT05406973
- Acronym / sponsor ID
- Kasr AlAini Hospital
- Conditions
- Refractive Surgery
- Keywords
- LASIK, SBK, femtolaser, flap creation, myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Eyecare Center
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jun 2022 (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.
LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. The disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. Recent studies have shown that SBK corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.
Detailed description
It is a prospective comparative non randomized interventional clinical study
Primary outcomes of this study include:
- Comparison between the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia using anterior segment OCT (AS-OCT) 1 month after surgery in each group of patients.
- Measuring corneal flap diameter using (AS-OCT)
Secondary outcomes:
- Measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month postoperative.
- Recording any related complications in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moria SBK microkeratome | Other | Device: SBK microkeratome versus femtosecond laser in flap creationComparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia |
| 200-kHz Femtosecond laser system | Other | Device: SBK microkeratome versus femtosecond laser in flap creationComparative non randomized Interventional clinical study between SBK microkeratome versus femtosecond laser in flap creation during LASIK surgery for myopia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Myopes (from -1 to -9), with astigmatism up to -4, normal corneal topography, central corneal thickness (CCT) more than 500 microns, and stable refraction for at least 12 months.
Key exclusion criteria (1 listed)
- CCT less than 500 microns, any ocular pathologies, one eyed patients, history of systemic disease, intraoperative complications, and abnormal corneal topography.
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 |
|---|---|---|
| SBK microkeratome versus femtosecond laser in flap creationprospective comparative non randomized interventional clinical study | Device | 200-kHz Femtosecond laser system, Moria SBK microkeratome |
Primary outcome
flap thickness accuracy
Time frame: 1 month post operative
comparison between the accuracy of the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia, 1 month after surgery using anterior segment OCT
1 secondary outcome
Visual Acuity measurment
Time frame: 1day, 1 week, 1 month after surgery
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 20 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Yehia Salah El Din, MD principal investigator
Professor of Ophthalmology, Kasr Al Aini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBK microkeratome versus femtosecond laser in flap creation in people with Refractive Surgery, run by Kasr El Aini Hospital 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 1 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: finished, as of the sponsor's last update on 20 Mar 2023. 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?
flap thickness accuracy (time frame: 1 month post operative). 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 20 Mar 2023.