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NCT00366743 Clinical Trial

Evaluation of Visual Outcomes After Myopic LASIK

Myopia Clinical Trial

Official title:
Analysis of Visual Outcomes, Contrast Sensitivity, Glare, Induction of High Order Aberrations and Wavefront Technology, Following LASIK Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00366743
Other study ID # MRC-05-001
Secondary ID
Status Completed
Phase N/A
First received August 17, 2006
Last updated August 17, 2006
Start date May 2003
Est. completion date June 2005

Study information
Verified date June 2005
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare testing and high order aberrations induced by different laser technologies and to evaluate differences in aberrometer technology. We hypothesized that there will not be differences among conventional or wavefront guided treatments.

Description:

The aim of the study was to evaluate and compare visual outcomes, contrast sensitivity, glare testing and induction of high order aberrations by different laser technologies and to evaluate differences in aberrometer technology.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

- 18 years or older

- Candidates for bilateral LASIK

- Myopic range: 0.00 to -7.00 D

- Astigmatism: 0.00 to -5.00 D

Exclusion Criteria:

- Pupil size greater than 8mm diameter, infrared measurement

- thin corneas (preoperatively calculated minimal residual bed < 250 um)

- irregular astigmatism

- asymmetric astigmatism

- unstable refraction

- other criteria that preclude the patient to undergo LASIK

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Conventional LASIK

• Wavefront-guided LASIK

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of South Carolina

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity
Primary Contrast sensitivity
Primary Induction of high order aberrations
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