A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia
December 7, 2011 updated by: Bausch & Lomb Incorporated
Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment
The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Myopia with or without astigmatism.
- Normal Corneal topography
- Willing to have both eyes treated with the laser.
Exclusion Criteria:
- Contraindications to LASIK.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Zyoptix Tissue Saving Aspheric
The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.
|
Used with LASIK treatment for the correction of myopia and myopic astigmatism.
|
|
ACTIVE_COMPARATOR: Zyoptix Tissue Saving
The Bausch & Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism.
|
Used with LASIK treatment for the correction of myopia and myopic astigmatism.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Uncorrected visual acuity
Time Frame: At 90 days post surgery
|
At 90 days post surgery
|
|
Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline.
Time Frame: At 90 days post surgery
|
At 90 days post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Deviation from target correction
Time Frame: At 90 days post surgery
|
At 90 days post surgery
|
|
Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline
Time Frame: At 90 days post surgery
|
At 90 days post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Joanne Egamino, PhD, Bausch & Lomb Incorporated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (ACTUAL)
March 1, 2006
Study Completion (ACTUAL)
March 1, 2006
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
August 15, 2006
First Posted (ESTIMATE)
August 17, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
December 8, 2011
Last Update Submitted That Met QC Criteria
December 7, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.