COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03193411
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):
magda torky, Dar Al Shifa Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Lasik in Myopia Device: Visumax femtosecond laser Device: Moria M2 microkeratome (MK) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visumax Femtolasik Versus Moria M2 Microkeratome in Mild to Moderate Myopia: Efficacy, Safety, Predictability, Aberrometric Changes and Flap Thickness Predictability
Actual Study Start Date : January 2014
Actual Primary Completion Date : May 29, 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
microkeratome group
30 eyes were treated by microkeratome
Device: Moria M2 microkeratome (MK)
femtosecond group
30 eyes were treated by femtosecond laser
Device: Visumax femtosecond laser

Primary Outcome Measures :
  1. visual outcomes [ Time Frame: 6 months ]
    uncorrected and best corrected distant visual acuity in LogMAR

  2. refractive outcomes [ Time Frame: 6 months ]
    sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03193411

Sponsors and Collaborators
Dar Al Shifa Hospital
Layout table for investigator information
Principal Investigator: Magda Torky daralshifa hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: magda torky, priniciple investigator, Dar Al Shifa Hospital Identifier: NCT03193411    
Other Study ID Numbers: 2315
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Refractive Errors
Eye Diseases