Comprehensive Evaluation of Visual Function

• Sponsor: The Chicago Lighthouse (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00894192
• Collaborator: Ophthonix Inc (Industry), University of Illinois at Chicago (Other)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 30.1

Study Details

Study Description

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	Phase
Visual Function	Device: Izon Wavefront-guided lenses; Device: Conventional lenses	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Feb 1, 2009
• Anticipated Primary Completion Date: Oct 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity, and Contrast Sensitivity [Once a week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Chicago Lighthouse	Chicago	Illinois	United States	60608

Sponsors and Collaborators

• The Chicago Lighthouse
• Ophthonix Inc
• University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00894192
• Other Study ID Numbers: OPH-2005-0516
• First Posted: May 6, 2009
• Last Update Posted: May 6, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.

Study Results

No Results Posted as of May 6, 2009