NCT01329848

Brief Summary

This project will develop clinically useful, objective measurements of accommodative insufficiency and fatigue using continuous autorefraction recordings. The development of these procedures will help vision care professionals diagnose and treat accommodative anomalies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 5, 2015

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

April 4, 2011

Results QC Date

December 8, 2014

Last Update Submit

December 23, 2014

Conditions

Keywords

AccommodationReadingAutorefraction

Outcome Measures

Primary Outcomes (1)

  • Accommodation Lag 5D

    Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.

    3 week period

Secondary Outcomes (1)

  • Conlon Symptom Survey

    3 weeks

Study Arms (1)

discomfort symptoms

level of discomfort symptoms while performing near work

Eligibility Criteria

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

Graduate students from Western University of Health Sciences

You may qualify if:

  • older adolescent and young adult
  • skilled readers who attend school
  • are skilled readers
  • have heavy reading demands

You may not qualify if:

  • Age \> 30.
  • Abnormal vergence system.
  • Dry-eye.
  • Uncorrected visual defects or significant ocular pathology.
  • Learning disability or low IQ
  • Medical conditions that might cause uncomfortable visual symptoms (e.g., migraine headaches, epilepsy, head trauma); sensory defects (e.g., deafness), or neurological conditions (e.g., stuttering) that could impair reading development or oral reading fluency.
  • Somatosensory amplification.
  • Systemic illness or medication associated with accommodative dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91766, United States

Location

Results Point of Contact

Title
Dr. Chris Chase
Organization
Western University of Health Sciences

Study Officials

  • Chris Chase, PhD

    Western University of Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Optometry

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 6, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2012

Study Completion

August 1, 2013

Last Updated

January 5, 2015

Results First Posted

January 5, 2015

Record last verified: 2014-12

Locations