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Defocus Induced Changes on Choroidal Thickness

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ClinicalTrials.gov Identifier: NCT03954886
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Lisa Ostrin, University of Houston

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Induced Defocus to the Retina Device: Plus powered optical lens Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Defocus on Choroidal Thickness
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Experimental: Induced myopic defocus
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
A plus powered optical lens will be placed in front of one eye.




Primary Outcome Measures :
  1. Choroidal thickness [ Time Frame: 1 hour ]
    Changes in choroidal thickness following induced myopic defocus



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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954886


Contacts
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Contact: Lisa Ostrin, OD, PhD 17138579983 laostrin@gmail.com

Locations
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United States, Texas
University of Houston College of Optometry Recruiting
Houston, Texas, United States, 77004
Contact: Lisa Ostrin, OD, PhD    713-857-9983    laostrin@gmail.com   
Sponsors and Collaborators
University of Houston

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Responsible Party: Lisa Ostrin, Assistant Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03954886     History of Changes
Other Study ID Numbers: STUDY00000852
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be provided by request once published
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: At any point after completion of the study and publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Lisa Ostrin, University of Houston:
Myopia
Choroid
Retina
Blur
Defocus
Eye growth