Viewing Study NCT00344864



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Study NCT ID: NCT00344864
Status: TERMINATED
Last Update Posted: 2011-03-23
First Post: 2006-06-23

Brief Title: A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations
Sponsor: University of Texas Southwestern Medical Center
Organization: University of Texas Southwestern Medical Center

Study Overview

Official Title: A Prospective Clinical Research Project Evaluating The Effects of Soft Contact Lenses on Higher Order Visual Aberrations
Status: TERMINATED
Status Verified Date: 2007-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Terminated due to lack of patient recruitment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 patients 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None