NCT00383175

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

3.2 years

First QC Date

September 29, 2006

Last Update Submit

February 17, 2011

Conditions

Ocular Accommodation

Keywords

Ocular AccommodationReading

Outcome Measures

Primary Outcomes (1)

  • DIBELS test scores .

    1 -2 years

Interventions

Autorefractor, standard clinical instrumentOTHER

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

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eutaw Primary School

Eutaw, Alabama, 35462, United States

Location

Study Officials

  • Robert Kleinstein, OD,MPH,PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

August 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

US(1)