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NCT00366769 Clinical Trial

Evaluation of Outcomes Following LASIK Surgery Using CustomVue

Myopia Clinical Trial

Official title:
Evaluation of Visual Outcomes, Contrast Sensitivity, Glare, and Induction of High Order Aberrations Following LASIK Surgery Using CustomVue

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00366769
Other study ID # MRC-05-005
Secondary ID
Status Completed
Phase N/A
First received August 17, 2006
Last updated August 17, 2006
Start date September 2005
Est. completion date February 2006

Study information
Verified date March 2006
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 and induced high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Myopia 0.00 to -6.00 D

- Astigmatism 0.00 up to -3.00 D

- Manifest refraction spherical equivalent (MRSE) up to -6.00 D.

Exclusion Criteria:

- History of ocular pathology

- Previous ocular surgery

- Large pupils (greater than 8mm diameter, infrared measurement)

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

- Irregular astigmatism

- Asymmetric astigmatism

- Unstable refraction

- Any other condition that precludes the patient from undergoing LASIK

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Wavefront-guided LASIK using CustomVue platform

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 Induction of high order aberrations
Secondary Contrast sensitivity & glare
Secondary Patient satisfaction
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