Evaluation of Outcomes Following LASIK Surgery Using CustomVue

NCT ID: NCT00366769

Last Updated: 2006-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia Astigmatism Myopic Astigmatism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Wavefront-guided LASIK using CustomVue platform

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Principal Investigators

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Kerry D. Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

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MRC-05-005

Identifier Type: -

Identifier Source: org_study_id