Defocus Induced Changes on Choroidal Thickness

Sponsor

University of Houston (Other)

Overall Status

Completed

CT.gov ID

NCT03954886

Collaborator

(none)

Enrollment

Location

Arms

43.6

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

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

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

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.
No Intervention: No defocus 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

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.

No Intervention: No defocus

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

Outcome Measures

Primary Outcome Measures

Choroidal thickness [1 hour]
Changes in choroidal thickness following induced myopic defocus

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston College of Optometry	Houston	Texas	United States	77004

Sponsors and Collaborators

University of Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lisa Ostrin, Assistant Professor, University of Houston

ClinicalTrials.gov Identifier:

NCT03954886

Other Study ID Numbers:

STUDY00000852

First Posted:

May 17, 2019

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Lisa Ostrin, Assistant Professor, University of Houston

Study Results

No Results Posted as of Mar 17, 2022