Comprehensive Evaluation of Visual Function
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Visual Function |
Device: Izon Wavefront-guided lenses Device: Conventional lenses |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Comprehensive Evaluation of Visual Function |
- Visual Acuity, and Contrast Sensitivity [ Time Frame: Once a week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| 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| Contact: Samar Suleman, BA | 312-447-3234 | samar.suleman@chicagolighthouse.org |
| 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 | |
More Information
No publications provided
| Responsible Party: | Janet Szlyk, PhD, The Chicago Lighthouse |
| ClinicalTrials.gov Identifier: | NCT00894192 History of Changes |
| Other Study ID Numbers: | OPH-2005-0516 |
| Study First Received: | May 4, 2009 |
| Last Updated: | May 5, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The Chicago Lighthouse for People Who Are Blind or Visually Impaired:
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This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses. |
ClinicalTrials.gov processed this record on May 16, 2013