NCT00347997|Withdrawn
Study Stopped
Decision made by B\&L to cancel the study, no subjects enrolled.
A Study to Evaluate the Safety and Effectiveness of the 217z Laser With Zyoptix for Lasik
1 other identifier
385
Study Type
interventional
Target
N/A
Locations
0 countries
Sites
N/A
Timeline
RegisteredJul 2006
Brief Summary
A Study to demonstrate the safety and efficacy of wavefront laser refractive surgery treatments for myopia and astigmatism.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2006
Completed4 days until next milestone
First Posted
Study publicly available on registry
July 4, 2006
CompletedLast Updated
December 8, 2011
Status Verified
December 1, 2011
First QC Date
June 30, 2006
Last Update Submit
December 7, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
24 months
Study Arms (1)
LASIK
EXPERIMENTALLASIK correction of myopia and myopic astigmatism
Device: 217z Laser
Interventions
Eligibility Criteria
Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
You may qualify if:
- Myopia with or without astigmatism.
You may not qualify if:
- Contraindications to LASIK.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
MyopiaAstigmatism
Condition Hierarchy (Ancestors)
Refractive ErrorsEye Diseases
Study Officials
- STUDY DIRECTOR
Mohinder Merchea, OD, PhD
Bausch & Lomb Incorporated
0
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2006
First Posted
July 4, 2006
Last Updated
December 8, 2011
Record last verified: 2011-12