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Peripheral Choroidal Layer Response

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
adaptive optics system
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myopia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  • Is between the ages of 18 and 40 yrs old
  • Has normal best corrected visual acuity being 20/20 or better
  • Has spherical refractive error between +1.00D and -6.00D.
  • Is capable of fixating on the target.
  • Has no prior ocular surgery.
  • Has no ocular pathology except keratoconus.
  • Can tolerate dilating eye drops

Exclusion Criteria:

A person will be excluded from the study if he/she:

  • Does not fall within above mentioned age group.
  • Has chronic or systemic eye disease that would interfere with pupil dilation via eye drops.
  • Underwent ocular surgeries or history of ocular trauma
  • Has shallow anterior chamber angle and/or glaucoma.
  • Has clinically significant dry eye.
  • Has signs of any choroidal or retinal pathology, and abnormalities in the visual pathway
  • Has spherical refractive error that exceeds the limits outlined above.
  • Has binocular anomalies (e.g. convergence insufficiency, strabismus, pseudo-myopia, amblyopia).
  • Is an adult unable to consent
  • Is an individual who is not yet adult (infants, children, teenagers)
  • Is a pregnant woman
  • Is a prisoner
  • Is a student for whom you have direct access to/influence on grades
  • Is an economically and/or educationally disadvantaged person

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    normal healthy group

    Arm Description

    Adaptive optics system: this system controls the optical quality of the eye at the peripheral visual field temporarily.

    Outcomes

    Primary Outcome Measures

    choroidal thickness
    A commercially available optical coherence tomography system will be used to measure changes in choroidal layer thickness before and after manipulating the peripheral optics.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2021
    Last Updated
    November 23, 2021
    Sponsor
    University of Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05132140
    Brief Title
    Peripheral Choroidal Layer Response
    Official Title
    Peripheral Choroidal Response to Pure Defocus and Oriented Blur Conditions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    November 2022 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Houston

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aims to examine how the vascular layer of the eyeball (choroidal layer) responds when part of the visual field is exposed to specially generated visual stimulus. The study goal will be accomplished by producing specific blur visual stimulus at a particular visual field position and measure any consistent thickness change pattern in the choroidal layer. We propose to test the hypothesis that regional changes in the choroidal thickness may be induced differently after short-term exposure to specific visual stimuli.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    normal healthy group
    Arm Type
    Experimental
    Arm Description
    Adaptive optics system: this system controls the optical quality of the eye at the peripheral visual field temporarily.
    Intervention Type
    Device
    Intervention Name(s)
    adaptive optics system
    Intervention Description
    the system consists of a wavefront sensor and a deformable mirror that measure and correct (or modify) the eye's optical imperfections (aberrations).
    Primary Outcome Measure Information:
    Title
    choroidal thickness
    Description
    A commercially available optical coherence tomography system will be used to measure changes in choroidal layer thickness before and after manipulating the peripheral optics.
    Time Frame
    up to 60 mins

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is between the ages of 18 and 40 yrs old Has normal best corrected visual acuity being 20/20 or better Has spherical refractive error between +1.00D and -6.00D. Is capable of fixating on the target. Has no prior ocular surgery. Has no ocular pathology except keratoconus. Can tolerate dilating eye drops Exclusion Criteria: A person will be excluded from the study if he/she: Does not fall within above mentioned age group. Has chronic or systemic eye disease that would interfere with pupil dilation via eye drops. Underwent ocular surgeries or history of ocular trauma Has shallow anterior chamber angle and/or glaucoma. Has clinically significant dry eye. Has signs of any choroidal or retinal pathology, and abnormalities in the visual pathway Has spherical refractive error that exceeds the limits outlined above. Has binocular anomalies (e.g. convergence insufficiency, strabismus, pseudo-myopia, amblyopia). Is an adult unable to consent Is an individual who is not yet adult (infants, children, teenagers) Is a pregnant woman Is a prisoner Is a student for whom you have direct access to/influence on grades Is an economically and/or educationally disadvantaged person
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Geunyoung Yoon, PhD
    Phone
    7137437860
    Email
    gyoon2@central.uh.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dibyendu Pusti, PhD
    Phone
    5854069837
    Email
    dpusti@central.uh.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Geunyoung Yoon, PhD
    Organizational Affiliation
    University of Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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