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OpenTrials
Completed

NCT Number: NCT03193411

Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visumax femtosecond laser

Device

Moria M2 microkeratome (MK)

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dar Al Shifa Hospital

Other

Registry information

Official study title

Visumax Femtolasik Versus Moria M2 Microkeratome in Mild to Moderate Myopia: Efficacy, Safety, Predictability, Aberrometric Changes and Flap Thickness Predictability

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2017
Registry last updated
Jun 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.