- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00383175
Reading Fluency and Accommodative Lag
February 17, 2011 updated by: University of Alabama at Birmingham
The purpose of this study is to determine whether special reading glasses improve children's ability to learn to read.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Eutaw, Alabama, United States, 35462
- Eutaw Primary School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
DIBELS test scores .
Time Frame: 1 -2 years
|
1 -2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robert Kleinstein, OD,MPH,PhD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
September 29, 2006
First Submitted That Met QC Criteria
September 29, 2006
First Posted (Estimate)
October 2, 2006
Study Record Updates
Last Update Posted (Estimate)
February 21, 2011
Last Update Submitted That Met QC Criteria
February 17, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F060328003
- EY008893 (Other Grant/Funding Number: NEI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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