Reading Fluency and Accommodative Lag

Ocular Accommodation Clinical Trial

Official title:

Reading Fluency and Accommodative Lag

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383175
• Other study ID #: F060328003
• Secondary ID: EY008893
• Status: Completed
• Phase: N/A
• First received: September 29, 2006
• Last updated: February 17, 2011
• Start date: August 2006
• Est. completion date: October 2009

Study information

• Verified date: February 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 9 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ocular Accommodation

Intervention

Other:
• Autorefractor, standard clinical instrument
Autorefractor, standard clinical instrument was used to assess the children's focusing power at near.

Locations

Country	Name	City	State
United States	Eutaw Primary School	Eutaw	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DIBELS test scores .		1 -2 years	No