Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

NCT ID: NCT03193411

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Lasik in Myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microkeratome group

30 eyes were treated by microkeratome

Group Type: OTHER

Moria M2 microkeratome (MK)

Intervention Type: DEVICE

femtosecond group

30 eyes were treated by femtosecond laser

Group Type: OTHER

Visumax femtosecond laser

Intervention Type: DEVICE

Interventions

Visumax femtosecond laser

Intervention Type: DEVICE

Moria M2 microkeratome (MK)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dar Al Shifa Hospital

OTHER

Sponsor Role: lead

Responsible Party

magda torky

priniciple investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magda Torky

Role: PRINCIPAL_INVESTIGATOR

daralshifa hospital

References

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.

Reference Type: DERIVED

PMID: 28716114 (View on PubMed)

Other Identifiers

2315

Identifier Type: -

Identifier Source: org_study_id