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Comprehensive Evaluation of Visual Function

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ClinicalTrials.gov Identifier: NCT00894192
Recruitment Status : Unknown
Verified May 2009 by The Chicago Lighthouse for People Who Are Blind or Visually Impaired.
Recruitment status was:  Recruiting
First Posted : May 6, 2009
Last Update Posted : May 6, 2009
Sponsor:
Collaborators:
Ophthonix Inc
University of Illinois at Chicago
Information provided by:
The Chicago Lighthouse for People Who Are Blind or Visually Impaired

Brief Summary:
The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.

Condition or disease Intervention/treatment
Visual Function Device: Izon Wavefront-guided lenses Device: Conventional lenses

Detailed Description:
The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comprehensive Evaluation of Visual Function
Study Start Date : February 2009
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Wavefront guided lenses Device: Izon Wavefront-guided lenses
Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.
Placebo Comparator: Conventional lenses Device: Conventional lenses
We will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses.



Primary Outcome Measures :
  1. Visual Acuity, and Contrast Sensitivity [ Time Frame: Once a week ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Have normal vision
  • Are far-sighted or near-sighted
  • Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894192


Contacts
Contact: Samar Suleman, BA 312-447-3234 samar.suleman@chicagolighthouse.org

Locations
United States, Illinois
The Chicago Lighthouse Recruiting
Chicago, Illinois, United States, 60608
Contact: Samar Suleman, BA    312-447-3234    samar.suleman@chicagolighthouse.org   
Principal Investigator: Janet Szlyk, PhD         
Sponsors and Collaborators
The Chicago Lighthouse for People Who Are Blind or Visually Impaired
Ophthonix Inc
University of Illinois at Chicago

Responsible Party: Janet Szlyk, PhD, The Chicago Lighthouse
ClinicalTrials.gov Identifier: NCT00894192     History of Changes
Other Study ID Numbers: OPH-2005-0516
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: May 6, 2009
Last Verified: May 2009

Keywords provided by The Chicago Lighthouse for People Who Are Blind or Visually Impaired:
This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.