NCT05132140

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 11, 2021

Last Update Submit

November 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 60 mins

Study Arms (1)

normal healthy group

EXPERIMENTAL

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

Device: adaptive optics system

Interventions

the system consists of a wavefront sensor and a deformable mirror that measure and correct (or modify) the eye's optical imperfections (aberrations).

normal healthy group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Geunyoung Yoon, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geunyoung Yoon, PhD

CONTACT

Dibyendu Pusti, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 24, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

May 1, 2023

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share