NCT05684224

Brief Summary

HYPOTHESIS:

  1. 1.Horizontal convergence tracked with Tobii glasses is a reliable substitute for accommodation in young myopes and hyperopes with normal accommodative amplitudes
  2. 2.Young mypopes and hyperopes demonstrate different reading behaviors during near work
  3. 3.Compare the accommodative responses measured with the Grand Seiko open-field autorefractor to those derived from the Tobii Glasses, when subjects wear (1) spectacle glasses, (2) single vision contact lenses (SVCLs), and (3) multifocal contact lenses (MFCLs).
  4. 4.Investigate subjects' natural and dynamic accommodative behaviors and eye postures during reading using the Tobii Glasses.
  5. 5.Compare the change in natural and dynamic accommodative behaviors and eye postures during reading between myopes and hyperopes using the Tobii Glasses.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 14, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

January 1, 2023

Last Update Submit

March 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Horizontal convergence

    Horizontal convergence will be tracked using the Tobii Glasses

    Horizontal convergence during reading will be measured using the Tobii Glasses continuously for 5 minutes

Interventions

Dynamic accommodation will be tracked using the Tobii Glasses

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults between 18 and 30 years of age. Subjects will be recruited from students at SUNY College of Optometry.

You may qualify if:

  • Age: Subjects who are 18 to 30 years old
  • Refractive error: Subjects with myopia between -1.00 and -5.00 D in each eye (n = 5), or hyperopia between +2.00 and +5.00 D in each eye (n = 5), determined by spherical equivalent using dry manifest refraction and binocular balance
  • Astigmatism \<= 0.75 D in each eye
  • Anisometropia \<= 1.50 D
  • BCVA at distance 20/20 in each eye
  • Habitual contact lens wears or willing to wear single vision and multifocal contact lenses during the 2nd study visit
  • Normal eye posture and accommodation
  • Good general and ocular health

You may not qualify if:

  • Strabismus at distance or near
  • Amblyopia
  • Significant anisometropia (\>1.50 D)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaoying Zhu

New York, New York, 10036, United States

RECRUITING

Central Study Contacts

Xiaoying Zhu, OD, PhD, MD, MS, FAAO

CONTACT

Robert McPeek, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 13, 2023

Study Start

December 14, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations