Defocus Induced Changes on Choroidal Thickness

Study Overview
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Brief Summary
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The goals of this study are to assess the short-term (10-60 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-60 minutes of monocular exposure to -5 diopters to +5 diopters of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.

Detailed Description
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The purpose of this study is to determine modifying factors inducing or protecting against the development or progression of myopia, or nearsightedness. Myopia has reached epidemic levels in urbanized countries, reaching up to 90% of the teenage and young adult population in urban Asia. Myopia represents a significant socioeconomic burden and poses a risk for associated ocular diseases such as retinal detachment, choroidal neovascularization, and glaucoma. The economic and public health burden of myopia are growing disproportionately to the population, spurring interest in the development of therapies to prevent occurrence or progression. Myopia generally occurs because the eye grows too long, with onset and progression occurring from about ages 6 to 20. Though much is known about factors that influence eye growth, the exact mechanisms by which they do so have not been elucidated. The goals of this study are to assess the short-term (10-50 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-50 minutes of monocular exposure to -5D to +5D of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.

Official Title
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Effects of Defocus on Choroidal Thickness

Conditions
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Induced Defocus to the Retina

Intervention / Treatment
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* Device: Plus powered optical lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6 to 45 years of age (preliminary studies indicate that children under 6 cannot sit for imaging, and subjects over 45 do not respond to the optical defocus with expected choroidal thickness changes) Best corrected visual acuity of 20/25 or better in better-seeing eye Exclusion Criteria: Age younger than 6 years or older than 45 Best corrected visual acuity worse than 20/25 in better-seeing eye Ocular pathology or prior ocular injury Heavily-pigmented choroid that precludes accurate measurement of choroidal thickness

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Induced myopic defocus<br>Subjects will view a television through a lens that induces blur to the retina for one hour. Images of the eye will be captured every 10 minutes | Device: Plus powered optical lens<br>* A plus powered optical lens will be placed in front of one eye.<br>|
| No Intervention: No defocus<br>Subjects will view a television through a lens that induces no blur to the retina for one hour. Images of the eye will be captured every 10 minutes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal thickness | Changes in choroidal thickness following induced myopic defocus | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Choroid, Retina, Blur, Defocus, Eye growth