Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

Lasik in Myopia Clinical Trial

Official title:

Visumax Femtolasik Versus Moria M2 Microkeratome in Mild to Moderate Myopia: Efficacy, Safety, Predictability, Aberrometric Changes and Flap Thickness Predictability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193411
• Other study ID #: 2315
• Status: Completed
• Phase: N/A
• First received: June 15, 2017
• Last updated: June 17, 2017
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2017
• Source: Dar Al Shifa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: May 29, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lasik in Myopia
• Myopia

Intervention

Device:
• Visumax femtosecond laser

• Moria M2 microkeratome (MK)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dar Al Shifa Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual outcomes	uncorrected and best corrected distant visual acuity in LogMAR	6 months
Primary	refractive outcomes	sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter	6 months