A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00344864
Collaborator
(none)
30
2
14.9
15
1

Study Details

Study Description

Brief Summary

High order aberrations (HOA) are visual phenomena that decrease quality of vision. Examples of high order aberration are glare, halos, decreased contrast sensitivity and shape distortion. They are caused by slight imperfections or distortions in the corneal surface. HOA are currently measured using a variety of FDA approved devices. For this study, the LADARWave (Alcon) will be used to measure HOA. This device uses a harmless beam of light. It is FDA approved and non-invasive. Contact lens induced high order aberrations have never been measured and reported in the literature. This work may provide information to guide future contact lens design.

Condition or Disease Intervention/Treatment Phase
  • Device: LADARWave

Detailed Description

Patients will be recruited from the Aston optometry clinic. The pool of patients included in the study will be from those who have voluntarily scheduled appointments for contact lenses. During the patient's initial visit, the study will be explained to them and they will have a choice of whether or not to take part with no penalty for refusal. If a patient agrees to take part in the study, they will have their HOA measured with the LADARWave instrument prior to contact lens insertion and right after contact lens insertion. Patients will then return for visits both one week and one month later for follow up measurements at the time of their regularly scheduled visits.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Outcome Measures

Primary Outcome Measures

  1. Whether Soft contact lenses induce High order aberrations (HOA) []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

All patients of any race and sex between the ages of 18-35 years of age who are not currently wearing contact lenses at their initial presentation. Only patients who voluntarily agree to participate in the study will be included. These potential subjects would be selected after reviewing and signing the Informed Consent (IC) as well as HIPAA authorization forms. The Principal Investigator (PI) or his designee will introduce the study to the patient, thoroughly explaining the details of the study. Copies of the forms will be placed in the patient medical record as well as given to study patient.

Exclusion Criteria:

Patients under the age of 18 or over the age of 35 will be excluded. Patients with any ocular pathology, previous eye surgery and/or uveitis will be excluded. Also, any patient who does not choose to participate will be excluded.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aston Ambulatory Care Center Dallas Texas United States 75390-8866
2 UTSW Medical Center At Dallas Dallas Texas United States 75390-8866

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Paul Sanchez, MD, UTSW Medical Center At Dallas
  • Study Chair: James McCulley, MD, UTSW Medical Center Dallas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00344864
Other Study ID Numbers:
  • Sanchez001
First Posted:
Jun 27, 2006
Last Update Posted:
Mar 23, 2011
Last Verified:
May 1, 2007
Keywords provided by , ,

Study Results

No Results Posted as of Mar 23, 2011