Evaluation of Outcomes Following LASIK Surgery Using CustomVue

August 17, 2006 updated by: Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

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

No

Genders Eligible for Study

All

Description

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 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual acuity
Induction of high order aberrations

Secondary Outcome Measures

Outcome Measure
Patient satisfaction
Contrast sensitivity & glare

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Kerry D. Solomon, MD, Medical University of South Carolina

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

September 1, 2005

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Estimate)

August 21, 2006

Last Update Submitted That Met QC Criteria

August 17, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-05-005

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.

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