Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

June 17, 2017 updated by: magda torky, Dar Al Shifa Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual outcomes
Time Frame: 6 months
uncorrected and best corrected distant visual acuity in LogMAR
6 months
refractive outcomes
Time Frame: 6 months
sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dar Al Shifa Hospital

Investigators

  • Principal Investigator: Magda Torky, Daralshifa hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

May 29, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

June 17, 2017

First Posted (Actual)

June 20, 2017

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 17, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lasik in Myopia

Clinical Trials on Moria M2 microkeratome (MK)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe