Comprehensive Evaluation of Visual Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Visual Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Wavefront guided lenses

Group Type ACTIVE_COMPARATOR

Izon Wavefront-guided lenses

Intervention Type DEVICE

Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.

Conventional lenses

Group Type PLACEBO_COMPARATOR

Conventional lenses

Intervention Type DEVICE

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.

Interventions

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Izon Wavefront-guided lenses

Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes