Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

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: Lasik in Myopia
• Intervention / Treatment: Device: Moria M2 microkeratome (MK); Device: Visumax femtosecond laser

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	uncorrected and best corrected distant visual acuity in LogMAR	6 months
refractive outcomes	sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter	6 months

Collaborators and Investigators

• Sponsor: Dar Al Shifa Hospital
• Investigators: Principal Investigator: Magda Torky, Daralshifa hospital

Publications and helpful links

General 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.

Study record dates

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: Eye Diseases; Refractive Errors; Myopia
• 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