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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01329848
Other study ID # 1R15EY021021
Secondary ID
Status Completed
Phase N/A
First received April 4, 2011
Last updated December 23, 2014
Start date December 2010
Est. completion date August 2013

Study information

Verified date December 2014
Source Western University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

This project studies accommodative function, the ability to focus while doing near work. Visual discomfort symptoms, such as headaches, sore eyes, and blurred vision are commonly associated with prolonged reading or other near work. Researchers have long suspected accommodative dysfunction was involved but most clinical studies have failed to establish a relationship between weak accommodation and symptoms or reading impairments. Recent research, however, has found that clinical measure overestimate accommodative function and encourage the use of objective, autorefraction methods to measure and study accommodative weakness. This project will accomplish three goals. First, using autorefraction objective reliable procedures will be developed for measuring accommodative lag, the difference between the target location and where the eye is focused. Second, experiments will measure in real-time the impact of accommodative lag on reading fluency and visual discomfort systems. Third, studies will explore the role of the slow adaptive component in accommodative weakness. This work will lead to better methods for diagnosing and treating accommodative disorders.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date August 2013
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- older adolescent and young adult

- skilled readers who attend school

- are skilled readers

- have heavy reading demands

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Western University of Health Sciences Pomona California

Sponsors (2)

Lead Sponsor Collaborator
Western University of Health Sciences Southern California College of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Conlon Symptom Survey Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms. 3 weeks No
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