Comprehensive Evaluation of Visual Function

Visual Function Clinical Trial

Official title:

Comprehensive Evaluation of Visual Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00894192
• Other study ID #: OPH-2005-0516
• Status: Recruiting
• Phase: N/A
• First received: May 4, 2009
• Last updated: May 5, 2009
• Start date: February 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: The Chicago Lighthouse for People Who Are Blind or Visually Impaired
• Contact: Samar Suleman, BA
• Phone: 312-447-3234
• Email: samar.suleman[@]chicagolighthouse.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Visual Function

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Chicago Lighthouse	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
The Chicago Lighthouse for People Who Are Blind or Visually Impaired	Ophthonix Inc, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity, and Contrast Sensitivity		Once a week	No