NCT00366769

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
Last Updated

August 21, 2006

Status Verified

March 1, 2006

First QC Date

August 17, 2006

Last Update Submit

August 17, 2006

Conditions

MyopiaAstigmatismMyopic Astigmatism

Outcome Measures

Primary Outcomes (2)

  • Visual acuity

  • Induction of high order aberrations

Secondary Outcomes (2)

  • Contrast sensitivity & glare

  • Patient satisfaction

Interventions

Wavefront-guided LASIK using CustomVue platformDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Kerry D. Solomon, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

September 1, 2005

Study Completion

February 1, 2006

Last Updated

August 21, 2006

Record last verified: 2006-03