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Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

Primary Purpose

Lasik in Myopia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Visumax femtosecond laser

Moria M2 microkeratome (MK)

About this trial

This is an interventional treatment trial for Lasik in Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

microkeratome group

femtosecond group

Arm Description

30 eyes were treated by microkeratome

30 eyes were treated by femtosecond laser

Outcomes

Primary Outcome Measures

visual outcomes

uncorrected and best corrected distant visual acuity in LogMAR

refractive outcomes

sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter

Secondary Outcome Measures

Full Information

NCT ID

NCT03193411

First Posted

June 15, 2017

Last Updated

June 17, 2017

Sponsor

Dar Al Shifa Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03193411

Brief Title

Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 2014 (Actual)

Primary Completion Date

May 29, 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dar Al Shifa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lasik in Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

microkeratome group

Arm Type

Other

Arm Description

30 eyes were treated by microkeratome

Arm Title

femtosecond group

Arm Type

Other

Arm Description

30 eyes were treated by femtosecond laser

Intervention Type

Device

Intervention Name(s)

Visumax femtosecond laser

Intervention Type

Device

Intervention Name(s)

Moria M2 microkeratome (MK)

Primary Outcome Measure Information:

Title

visual outcomes

Description

uncorrected and best corrected distant visual acuity in LogMAR

Time Frame

6 months

Title

refractive outcomes

Description

sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magda Torky

Organizational Affiliation

daralshifa hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28716114

Citation

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.

Results Reference

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Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia

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