Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

Not Applicable

Completed

• Conditions: Lasik in Myopia
• Interventions: Device: Moria M2 microkeratome (MK); Device: Visumax femtosecond laser

• Registration Number: NCT03193411
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2014-05-29
• Study Completion: 2014-06
• Status Verified: 2017-06
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-17
• Last Update Submitted: 2017-06-17
• Study First Posted: 2017-06-20
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microkeratome group	Moria M2 microkeratome (MK)	30 eyes were treated by microkeratome
femtosecond group	Visumax femtosecond laser	30 eyes were treated by femtosecond laser

Primary Outcome Measures

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