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

This study has been terminated.
(Terminated due to lack of patient recruitment)
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344864
First received: June 23, 2006
Last updated: March 22, 2011
Last verified: May 2007
  Purpose

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 Intervention
Ocular Refractive Aberrations
Device: LADARWave

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Whether Soft contact lenses induce High order aberrations (HOA)

Estimated Enrollment: 30
Study Start Date: January 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344864

Locations
United States, Texas
UTSW Medical Center At Dallas
Dallas, Texas, United States, 75390-8866
Aston Ambulatory Care Center
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
  More Information

No publications provided

Responsible Party: Paul Sanchez, MD, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00344864     History of Changes
Other Study ID Numbers: Sanchez001
Study First Received: June 23, 2006
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Contact Lenses Higher Order Aberrations

ClinicalTrials.gov processed this record on August 01, 2014