Trial Comparing Patching With Active Vision Therapy to Patching With Control Vision Therapy as Treatment for Amblyopia

Summary

This study is comparing the effectiveness of patching combined with active vision therapy plus near activities versus patching combined with control vision therapy plus near activities for moderate amblyopia (20/40-20/100) in 7 to \<13 year olds.

The primary outcome measure is the proportion of patients with visual acuity of 20/25 or better in the amblyopic eye at the 17-week masked exam. These patients will be considered treatment responders. The primary analysis will consist of a comparison between the 2 treatment groups of the proportion of treatment responders with adjustment for baseline visual acuity.

Secondary outcomes are stereoacuity at the 17-week masked exam, mean improvement in visual acuity at the 17-week masked exam, and rate of improvement of visual acuity.

Conditions

• Amblyopia

Interventions

DEVICE

Patching

2 hours daily patching

PROCEDURE

Near activities

30 minutes daily near activities at home

PROCEDURE

Active vision therapy

30 minutes of daily at-home active vision therapy and a weekly 45 minute in-office active vision therapy session

PROCEDURE

Control vision therapy

30 minutes of daily at-home control vision therapy and a weekly 45 minute in-office control vision therapy session

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Don W. Lyon, O.D. · Indiana University

• David T. Wheeler, M.D. · Casey Eye Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2009-03-31

Completion

2009-10-31

Countries

• United States

Study Locations