Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Reading Fluency and Accommodative Lag

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00383175
First received: September 29, 2006
Last updated: February 17, 2011
Last verified: February 2011
  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
Other: Autorefractor, standard clinical instrument

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 ]

Enrollment: 72
Study Start Date: August 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Autorefractor, standard clinical instrument
    Autorefractor, standard clinical instrument was used to assess the children's focusing power at near.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
Eutaw Primary School
Eutaw, Alabama, United States, 35462
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Robert Kleinstein, OD,MPH,PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: R. Kleinstein and J. Sims, UAB
ClinicalTrials.gov Identifier: NCT00383175     History of Changes
Other Study ID Numbers: F060328003, EY008893
Study First Received: September 29, 2006
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Ocular Accommodation
Reading

ClinicalTrials.gov processed this record on November 27, 2014