Lasik in MyopiaNCT03193411
Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia
A study testing Visumax femtosecond laser and Moria M2 microkeratome (MK) in people with Lasik in Myopia, run by Dar Al Shifa Hospital.
Trial summary
this is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Lasik in Myopia
- What is being tested?
- Visumax femtosecond laser and Moria M2 microkeratome (MK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2014
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients were eligible for the study if they were older than 18 years and younger than 40 years.
- Stable myopia up to -6.0D and astigmatism up to -3.0D determined by manifest refraction for at least 6 months.
- best corrected distance visual acuity of at least 20/20, and stable keratometry after cessa¬tion of soft contact lens wear for at least 2 weeks.
Who cannot join
- any anterior seg¬ment pathology.
- any form of retinal degeneration. unstable myopia.
- severe dry eye.
- corneal thickness that would have resulted in less than 300 µm residual stromal thickness.
- Patients who had keratoconus or were keratoconus suspects.
- previous ocular sur¬gery.
Show all 9Show fewer
- a history of herpes zoster ophthalmicus or herpes simplex keratitis.
- a history of a steroid-responsive rise in in¬traocular pressure (IOP) or a preoperative IOP of more than 21 mmHg.
- diabetes mellitus, autoimmune dis¬ease, connective tissue disease, and chronic use of systemic corticosteroid or immunosuppressive therapy were also excluded from the study.
About this study
Official title: Visumax Femtolasik Versus Moria M2 Microkeratome in Mild to Moderate Myopia: Efficacy, Safety, Predictability, Aberrometric Changes and Flap Thickness Predictability
this is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia.
Read the detailed description
This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement.
- Conditions
- Lasik in Myopia
- Being tested
- Visumax femtosecond laser, Moria M2 microkeratome (MK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visumax femtosecond laserDevice
Moria M2 microkeratome (MK)Device
| Study group | Role | What they receive |
|---|---|---|
| microkeratome group | Other | 30 eyes were treated by microkeratome Receives: Device: Moria M2 microkeratome (MK) |
| femtosecond group | Other | 30 eyes were treated by femtosecond laser Receives: Device: Visumax femtosecond laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual outcomes
uncorrected and best corrected distant visual acuity in LogMAR
Measured: 6 months
refractive outcomes
sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study startJan 2014
- Primary completion29 May 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lasik in MyopiaStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dar Al Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, magda torky, Dar Al Shifa Hospital
- Investigators
- Magda Torky, Principal investigator, daralshifa hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193411
- Sponsor's protocol ID
- 2315
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torky MA, Al Zafiri YA, Khattab AM, Farag RK, Awad EA. Visumax femtolasik versus Moria M2 microkeratome in mild to moderate myopia: efficacy, safety, predictability, aberrometric changes and flap thickness predictability. BMC Ophthalmol. 2017 Jul 17;17(1):125. doi: 10.1186/s12886-017-0520-5.
PubMed 28716114
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visumax Femtolasik Versus Moria M2 Microkeratome in Mild to Moderate Myopia: Efficacy, Safety, Predictability, Aberrometric Changes and Flap Thickness Predictability
- ClinicalTrials.gov ID
- NCT03193411
- Acronym / sponsor ID
- 2315
- Conditions
- Lasik in Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dar Al Shifa HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 29 May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jun 2017 (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 is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia.
Detailed description
This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microkeratome group | Other | Device: Moria M2 microkeratome (MK)30 eyes were treated by microkeratome |
| femtosecond group | Other | Device: Visumax femtosecond laser30 eyes were treated by femtosecond laser |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female patients were eligible for the study if they were older than 18 years and younger than 40 years.
- Stable myopia up to -6.0D and astigmatism up to -3.0D determined by manifest refraction for at least 6 months.
- best corrected distance visual acuity of at least 20/20, and stable keratometry after cessa¬tion of soft contact lens wear for at least 2 weeks.
Key exclusion criteria (9 listed)
- any anterior seg¬ment pathology.
- any form of retinal degeneration. unstable myopia.
- severe dry eye.
- corneal thickness that would have resulted in less than 300 µm residual stromal thickness.
- Patients who had keratoconus or were keratoconus suspects.
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 |
|---|---|---|
| Visumax femtosecond laser | Device | femtosecond group |
| Moria M2 microkeratome (MK) | Device | microkeratome group |
Primary outcome
visual outcomes
Time frame: 6 months
uncorrected and best corrected distant visual acuity in LogMAR
refractive outcomes
Time frame: 6 months
sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter
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 Jun 2017.
- Derived from this study: PubMed 28716114Torky MA, Al Zafiri YA, Khattab AM, Farag RK, Awad EA. Visumax femtolasik versus Moria M2 microkeratome in mild to moderate myopia: efficacy, safety, predictability, aberrometric changes and flap thickness predictability. BMC Ophthalmol. 2017 Jul 17;17(1):125. doi: 10.1186/s12886-017-0520-5.
- 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.
Magda Torky principal investigator
daralshifa hospital
Questions about this trial
What is this clinical trial studying?
A study testing Visumax femtosecond laser and Moria M2 microkeratome (MK) in people with Lasik in Myopia, run by Dar Al Shifa Hospital.
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 3 inclusion and 9 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 Jun 2017. 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?
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?
visual outcomes (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT03193411, which also lists 1 linked publication.
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 Jun 2017.