Comprehensive Evaluation of Visual Function

May 5, 2009 updated by: The Chicago Lighthouse
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity, and Contrast Sensitivity
Time Frame: Once a week
Once a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Chicago Lighthouse

Collaborators

University of Illinois at Chicago
Ophthonix Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2009

Last Update Submitted That Met QC Criteria

May 5, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPH-2005-0516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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