Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia


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This study has been completed.

Sponsor:

Information provided by (Responsible Party):

magda torky, Dar Al Shifa Hospital

ClinicalTrials.gov Identifier:

NCT03193411

First received: June 15, 2017

Last updated: June 17, 2017

Last verified: June 2017

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.

Lasik in Myopia Device: Visumax femtosecond laser Device: Moria M2 microkeratome (MK)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Primary Outcome Measures:

  • 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

Enrollment: 30
Actual Study Start Date: January 2014
Study Completion Date: June 2014
Primary Completion Date: May 29, 2014 (Final data collection date for primary outcome measure)
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

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.

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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03193411

Dar Al Shifa Hospital

Principal Investigator: Magda Torky daralshifa hospital

Responsible Party: magda torky, priniciple investigator, Dar Al Shifa Hospital
ClinicalTrials.gov Identifier: NCT03193411     History of Changes
Other Study ID Numbers: 2315
Study First Received: June 15, 2017
Last Updated: June 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on June 20, 2017