Reading Fluency and Accommodative Lag

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, February 2009

First Received: September 29, 2006 Last Updated: February 12, 2009 History of Changes

Sponsors and Collaborators:	University of Alabama at Birmingham National Eye Institute (NEI)
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00383175

Purpose

The purpose of this study is to determine whether special reading glasses improve children's ability to learn to read.

Condition	Intervention
Ocular Accommodation	Device: Ophthalmic lenses

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Reading Fluency and Accommodative Lag

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

DIBELS test scores . [ Time Frame: 1 -2 years ] [ Designated as safety issue: No ]
DIBEL score [ Time Frame: 1 - 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Ophthalmic lenses

Detailed Description:

Many children are believed to under accommodate (have a lag of accommodation) when looking at near targets. If this occurs, the retinal image is out of focus. Children who have a lag of accommodation may have difficulty in focusing their eyes at near for long periods of time. This difficulty could reduce their ability to read fluently. Children with above average lags of accommodation will be randomly assigned to a group which receives special reading glasses or a group which does not. The groups will be assessed using a standard test for reading fluency.

Eligibility

Ages Eligible for Study:	5 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Children in grades 1, 2 and 3 who consent and assent to participate

Exclusion Criteria:

Children in the special education program
Children who are unwilling to have their eyes dilated or be tested
Children who are unwilling to wear the glasses

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383175

Contacts

Contact: Robert Kleinstein, OD,MPH,PhD	205-934-3036	vista@uab.edu
Contact: Janene Sims, OD,PhD	205-934-0366	jasims@uab.edu

Locations

United States, Alabama
Eutaw Primary School	Recruiting
Eutaw, Alabama, United States, 35462
Principal Investigator: Janene Sims, OD, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

National Eye Institute (NEI)

Investigators

Principal Investigator:

Robert Kleinstein, OD,MPH,PhD

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	UAB ( R. Kleinstein and J. Sims )
Study ID Numbers:	F060328003, EY008893
Study First Received:	September 29, 2006
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00383175 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

Ocular Accommodation
Reading

ClinicalTrials.gov processed this record on May 07, 2009