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

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.

Study Overview

• Status: Terminated
• Conditions: Ocular Refractive Aberrations
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-8866
      • Aston Ambulatory Care Center
    • Dallas, Texas, United States, 75390-8866
      • UTSW Medical Center at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Whether Soft contact lenses induce High order aberrations (HOA)

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: June 23, 2006
• First Submitted That Met QC Criteria: June 23, 2006
• First Posted (Estimate): June 27, 2006

Study Record Updates

• Last Update Posted (Estimate): March 23, 2011
• Last Update Submitted That Met QC Criteria: March 22, 2011
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Contact Lenses Higher Order Aberrations
• Other Study ID Numbers: Sanchez001