Autorefractor, standard clinical instrument in Ocular Accommodation - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Ocular Accommodation

Intervention / Treatment

Other: Autorefractor, standard clinical instrument

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

United States
- 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.

Sponsor

University of Alabama at Birmingham

Collaborators

National Eye Institute (NEI)

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