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Evaluation of Visual Outcomes After Myopic LASIK

Primary Purpose

Myopia, Astigmatism, Myopic Astigmatism

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Conventional LASIK

Wavefront-guided LASIK

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Visual acuity

Contrast sensitivity

Induction of high order aberrations

Secondary Outcome Measures

Full Information

NCT ID

NCT00366743

First Posted

August 17, 2006

Last Updated

August 17, 2006

Sponsor

Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT00366743

Brief Title

Evaluation of Visual Outcomes After Myopic LASIK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2005

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of South Carolina

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia, Astigmatism, Myopic Astigmatism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Conventional LASIK

Intervention Type

Procedure

Intervention Name(s)

Wavefront-guided LASIK

Primary Outcome Measure Information:

Title

Visual acuity

Title

Contrast sensitivity

Title

Induction of high order aberrations

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerry D. Solomon, MD

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Visual Outcomes After Myopic LASIK

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