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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03193411
Enrollment
30
Registered
2017-06-20
Start date
2014-01-31
Completion date
2014-06-30
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lasik in Myopia

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.

Interventions

DEVICEVisumax femtosecond laser
DEVICEMoria M2 microkeratome (MK)

Sponsors

Dar Al Shifa Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
visual outcomes6 monthsuncorrected and best corrected distant visual acuity in LogMAR
refractive outcomes6 monthssphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026