Clinical Trial: Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)

Brief Summary: CITT-ART is a multicenter study (8 locations around the United States) of 324 children ages 9 to <14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based therapy for convergence insufficiency (CI) improves reading ability and attention. CI is an eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention

Detailed Summary:

Following the success of the NEI-funded Convergence Insufficiency Treatment Trials (CITT), the next logical and important research issue is to determine if the successful treatment of symptomatic convergence insufficiency (CI) (i.e., improvement of symptoms and ophthalmic signs) impacts function (reading and attention).

It is well documented that children with symptomatic CI report significantly more symptoms when reading and doing close work (e.g., blurred vision, headaches, double vision, loss of concentration, frequent loss of place, trouble remembering what was read), manifest more academic-impairing behaviors (e.g., difficulty finishing assignments), and score worse on parent ratings of attention compared to children with normal binocular vision. Because reduction of symptoms and adverse academic behaviors are established outcomes of successful treatment of CI, we propose to test the hypothesis that resolution of these symptoms and behaviors leads to improved reading performance and attention. Previous studies have found improvements in reading comprehension reading speed and accuracy after successful treatment of CI. In a recent pilot study, investigators also found significant improvement in reading comprehension and attention after 16 weeks of successful treatment of symptomatic CI with office-based vergence/accommodative therapy; however, there was no control group. To definitively determine whether the successful treatment of symptomatic CI positively impacts reading and attention requires a placebo-controlled randomized clinical trial.

Objective: We propose a multicenter, placebo-controlled, randomized clinical trial (RCT) of 324 children ages 9 to <14 years (Grades 3-8) with symptomatic CI. [we will restrict recruitment to children who do not have significant single word reading deficits.] Participants will
Sponsor: Salus University

Current Primary Outcome: The change in the Wechsler Individual Achievement Test-III (WIAT-III) reading comprehension score as measured after the completion of 16 weeks of assigned treatment (OBVAT or OBPT). [ Time Frame: After 16 weeks of treatment ]

This test requires the examinee to respond to multiple-choice questions after having read passages independently.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The change in the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN) [ Time Frame: After 16 weeks of treatment ]
    The SWAN is a behavior rating scale that has been used for many years as an assessment tool for ADHD.
  • Gates-McGintie 4 [ Time Frame: After 16 weeks of treatment ]
    The child must respond to multiple-choice questions after having read passages independently
  • d2 Test of Attention [ Time Frame: After 16 weeks of treatment ]
    The d2 is a timed test of selective and sustained attention.The test measures processing speed, rule compliance, and quality of performance in response to the discrimination of similar stimuli, thereby allowing for an estimation of individual attention and concentration performance
  • Academic Behavior Survey (ABS) [ Time Frame: After 16 weeks of treatment ]
    The ABS is a 6-item survey designed to measure the frequency of adverse academic behaviors and parental worry about academic performance.
  • Curriculum Based Measurement (CBM) [ Time Frame: After 16 weeks of treatment ]
    Curriculum Based Measurement is commonly used by educators to assess short-term progress in reading, skills as the child proceeds through the academic year The primary advantage of the CBM measure is the ability to track rate of improvement by initial reading level and by time of year. The addition of the CBM measure will assess reading at each outcome visit and allow us to track changes in a similar manner to attention and CI where we have measures at each outcome visit. In addition, CBM will provide an additional outcome measure for reading using a method that is commonly employed by school districts to monitor reading progress and will help to communicate the clinical significance of our results.


Original Secondary Outcome: Same as current

Information By: Salus University

Dates:
Date Received: July 31, 2014
Date Started: May 2014
Date Completion: April 2019
Last Updated: April 24, 2017
Last Verified: April 2017