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| Sponsored by: |
University of Texas Southwestern Medical Center |
|---|---|
| Information provided by: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00344864 |
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 Abberations |
Device: LADARWave |
| Study Type: | Observational |
| Official Title: | A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations |
| Enrollment: | 0 |
| Study Start Date: | January 2006 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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 |
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| United States, Texas | |
| UTSW Medical Center At Dallas | |
| Dallas, Texas, United States, 75390-8866 | |
| Aston Ambulatory Care Center | |
| Dallas, Texas, United States, 75390-8866 | |
| Principal Investigator: | Paul Sanchez, MD | UTSW Medical Center At Dallas |
| Study Chair: | James McCulley, MD | UTSW Medical Center Dallas |
More Information
| Responsible Party: | UTSW Medical Center at Dallas ( Paul Sanchez, MD ) |
| Study ID Numbers: | Sanchez001 |
| Study First Received: | June 23, 2006 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00344864 |
| Health Authority: | United States: Institutional Review Board |
|
Contact Lenses Higher Order Abberations |
