Visumax Femtolasik Versus Moria M2 Microkeratome in Myopia
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedJune 20, 2017
June 1, 2017
5 months
June 15, 2017
June 17, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
visual outcomes
uncorrected and best corrected distant visual acuity in LogMAR
6 months
refractive outcomes
sphere in diopter, cylinder in diopter cylinder and spherical equivalent in diopter
6 months
Study Arms (2)
microkeratome group
OTHER30 eyes were treated by microkeratome
femtosecond group
OTHER30 eyes were treated by femtosecond laser
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28716114DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Magda Torky
daralshifa hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- priniciple investigator
Study Record Dates
First Submitted
June 15, 2017
First Posted
June 20, 2017
Study Start
January 1, 2014
Primary Completion
May 29, 2014
Study Completion
June 1, 2014
Last Updated
June 20, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share