NCT05134896

Brief Summary

Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Moreover, how central and peripheral vision interacts remains unclear. To conduct the study, we will use an adaptive optics vision simulator equipped with a Shack-Hartmann wavefront sensor and a spatial light modulator (see details in procedures section of the protocol). This system is capable of noninvasively controlling the eye's optical quality and evaluating visual performance simultaneously over a wide area of visual space. This study provides insights into the visual performance in the periphery visual field, and interaction between central and peripheral visual fields. The goal of this study is to evaluate the visual performance at central and peripheral visual fields after correcting the ocular aberrations. An optical system equipped with a liquid crystal spatial light modulator will be used to achieve this goal non-invasively.

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
30

participants targeted

Target at below P25 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

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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
15 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 26, 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 (3)

  • Visual acuity

    Snellen "Tumbling E" method will be used to determine the smallest letter that a subject can see.

    up to 6 separate sessions (each session taking up to 2 hours)

  • Contrast sensitivity

    Light and dark sinusoidal stripes (Gabor gratings) will used to determine the smallest contrast that a subject can see

    up to 6 separate sessions (each session taking up to 2 hours)

  • Contrast perception

    Light and dark sinusoidal stripes (Gabor gratings) will used to determine differences in contrast perceived by the central and peripheral visual system

    up to 6 separate sessions (each session taking up to 2 hours)

Study Arms (1)

normal healthy group

EXPERIMENTAL

Spatial light modulator

Device: Spatial light modulator

Interventions

This device compensates for the eye's optical imperfections (aberrations) at the foveal and peripheral retina.

normal healthy group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Is between the ages of 18 and 60.
  • Has normal corneas i.e. no corneal infections, no systemic pink eye, no clinically significant dry eye, and no corneal dystrophies.
  • Has refractive errors less than +/- 10.0 Diopters in both eyes.

You may not qualify if:

  • A person will be excluded from the study if he/she:
  • Adults between the ages of 18-60 who are unable to give informed consent
  • Individuals below 18 years old
  • Individuals above the age of 60
  • Pregnant women (self-reporting, hormonal changes may alter the refractive status of the eye)
  • Prisoners
  • Students for whom you have direct access to/influence on grades
  • People who do not understand or speak English
  • Has clinically significant dry eye.
  • Has clinically significant cataract.
  • Has spherical refractive error that exceeds the limits outlined above.
  • Is unable to hold his or her head steady for the duration of study measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Geunyoung Yoon, PhD

CONTACT

Jiakai Lyu, MS

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 26, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

March 1, 2023

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share