Peripheral Choroidal Layer Response

Myopia Clinical Trial

Official title:

Peripheral Choroidal Response to Pure Defocus and Oriented Blur Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05132140
• Other study ID #: STUDY00003210
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: May 2023

Study information

• Verified date: November 2021
• Source: University of Houston
• Contact: Geunyoung Yoon, PhD
• Phone: 7137437860
• Email: gyoon2[@]central.uh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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