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Office-based Vision Therapy for Improving Reading and Attention in Children With Convergence Insufficiency (CITT-ART)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Mitchell Scheiman, Salus University
Sponsor:
Collaborators:
National Eye Institute (NEI)
Marshall B. Ketchum University
Ohio State University
University of Alabama at Birmingham
State University of New York College of Optometry
Akron Children's Hospital
Nova Southeastern University
Bascom Palmer Eye Institute
Information provided by (Responsible Party):
Mitchell Scheiman, Salus University
ClinicalTrials.gov Identifier:
NCT02207517
First received: July 31, 2014
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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

Condition Intervention Phase
Convergence Insufficiency Procedure: Office-based vergence/accommodative therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Convergence Insufficiency Treatment Trial - Attention and Reading Trial (CITT-ART)

Resource links provided by NLM:


Further study details as provided by Mitchell Scheiman, Salus University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 324
Study Start Date: May 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Office-based verg/accomm therapy (OBVAT)
OBVAT requires a participant to undergo a specific vision therapy regimen with 16 weekly, 60-minute in-office treatment sessions. Vision Therapists (O.D., M.D., Orthoptists, or specially-trained technicians) administer the therapy in the office. OBVAT procedures are then supplemented with various home therapy procedures
Procedure: Office-based vergence/accommodative therapy
The OBVAT program has been divided into 4 phases. Within each phase there are a number of categories such as gross convergence, vergence, and accommodation. The therapy procedures in each category have been arranged sequentially from easiest to most difficult
Other Names:
  • Vision Therapy
  • Orthoptics
Placebo Comparator: Office-based placebo therapy (OBPT)

Office-based Placebo Therapy (OBPT) requires a participant to undergo a specific therapy regimen of 16 weekly, 60 minute, in-office treatment sessions. Vision therapists (optometrists, ophthalmologists, orthoptists, or specially-trained technicians) administer the therapy in the office. OBPT procedures are then supplemented with placebo home therapy procedures.

The procedures for OBPT are designed with the intent of not providing a beneficial training effect on vergence, accommodation, saccadic accuracy, or visual attention beyond normal activities. However, the procedures are designed to simulate real vision therapy in such a way that it will be difficult for participants and parents to know that they have been assigned to the control group and thus are not receiving bonafide OBVAT

Procedure: Office-based vergence/accommodative therapy
The OBVAT program has been divided into 4 phases. Within each phase there are a number of categories such as gross convergence, vergence, and accommodation. The therapy procedures in each category have been arranged sequentially from easiest to most difficult
Other Names:
  • Vision Therapy
  • Orthoptics

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 9 to less than 14 years
  2. Grades 3 through 8
  3. CI Symptom Survey (CISS) score greater or equal to 16
  4. Exophoria at near at least 4 prism diopters greater than at far
  5. Receded near point of convergence (NPC) of 6 cm or greater break
  6. Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's or PFV less than or equal to 15 BO break)
  7. Best-corrected distance visual acuity of 20/25 or better in each eye
  8. Random dot stereopsis appreciation of 500 seconds of arc or better
  9. Wearing appropriate refractive correction (spectacles or contact lenses) for at least 2 weeks prior to final determination of eligibility for any of the following uncorrected refractive errors (based on cycloplegic refraction within prior 12 months)

    • Myopia greater than -0.75D spherical equivalent (SE) in either eye
    • Hyperopia greater than +2.00D SE in either eye
    • SE anisometropia greater than 0.75D
    • Astigmatism greater than 1.00D in either eye

    Correction for patients meeting above refractive error criteria must meet the following guidelines:

    • SE anisometropia must be within 0. 75D of the full anisometropic correction
    • Astigmatism must be within 0.75D of full correction; axis must be within 6◦ if astigmatism greater than or equal to 1.00D
    • For hyperopia, the sphere can be reduced by up to 1.50 D provided reduction is symmetrical
    • For myopia, the SE must be within 0.75D of the full myopic correction
  10. No use of BI prism or plus add at near for 2 weeks prior to study and for duration of study
  11. English is primary language spoken at home or child proficient in English as determined by the school
  12. Parent does not expect child to start any new ADHD medicine or change the dose of any currently taken ADHD medicine while child is being treated in the study
  13. Parental permission to contact the child's teacher(s) for study purposes
  14. Parent and child understand protocol and are willing to accept randomization

Exclusion Criteria:

  1. Constant strabismus at distance or near
  2. Esophoria of greater than or equal to 2∆ at distance
  3. Vertical heterophoria greater than or equal to 2∆ at distance or near
  4. greater than or equal to 2 line interocular difference in best-corrected distance visual acuity
  5. Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye
  6. Manifest or latent nystagmus
  7. Word Reading subtest score less than 80 on the Wide Range Achievement Test (WRAT-4)
  8. Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score less than 70
  9. History of prior strabismus, intraocular, or refractive surgery
  10. CI previously treated with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
  11. CI associated with head trauma or known disease of the brain
  12. Diseases known to affect accommodation, vergence, or ocular motility
  13. Inability to comprehend and/or perform any study-related test or therapy procedure
  14. Speech-language disorder (e.g., stuttering) that would interfere with interpretation of digital recordings of reading tests
  15. Significant hearing loss
  16. Household member enrolled in present CITT-ART, treated currently, or treated within the past 6 months with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
  17. Parent or other household member is an eye care professional, ophthalmic technician, ophthalmology or optometry resident, or optometry student
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02207517

Contacts
Contact: Mitchell Scheiman, OD 215-780-1427 mscheiman@salus.edu
Contact: Karen Pollack 215-276-6053 kpollack@salus.edu

Locations
United States, Alabama
University of Alabama, Birmingham College of Optometry Recruiting
Birmingham, Alabama, United States, 35294
Contact: Wendy Marsh-Tootle, OD    205-934-5702    wmarsht@uab.edu   
Contact: Michelle Bowan    205-996-4874    mbbowen@uab.edu   
Principal Investigator: Wendy Marsh-Tootle, OD, MS         
United States, California
Southern California College of Optometry Marshall B. Ketchum University Recruiting
Fullerton, California, United States, 90037
Contact: Susan Cotter, OD, MS    714-449-7488    scotter@ketchum.edu   
Contact: Susan Parker    714-992-7817    sparker@ketchum.edu   
Principal Investigator: Susan Cotter, OD, MS         
United States, Florida
NOVA Southeastern University College of Optometry Recruiting
Fort Lauderdale, Florida, United States, 33314
Contact: Rachel Coulter, OD    954-262-1438    staceyco@nova.edu   
Contact: Annette Bade, OD    954-262-1436    abade@nova.edu   
Principal Investigator: Rachel Coulter, OD         
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Susanna Tamkins, OD    305-326-6000    stamkins@med.miami.edu   
Contact: Carolina Manchola-Orozco    305-482-4016    cmorozco@med.miami.edu   
Principal Investigator: Susanna Tamkins, OD         
United States, New York
State University of Optometry College of Optometry Recruiting
New York, New York, United States, 10036
Contact: Jeffrey Cooper, OD, MS    212-938-4052    cooperjsc1@gmail.com   
Contact: Sara Meeder, OD    212-938-4052    smeeder@sunyopt.edu   
Principal Investigator: Jeffrey Cooper, OD, MS         
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44302
Contact: Richard Hertle, MD    330-535-0778    rhertle@chmca.org   
Contact: Tonia Polanski    330-543-4466    TPolanski@chmca.org   
Principal Investigator: Richard Hertle, MD         
Ohio State University College of Optometry Recruiting
Columbus, Ohio, United States, 43210
Contact: Marjean Kulp, OD, MS    614-688-3336    kulp.6@osu.edu   
Contact: Nancy Stevens    614-247-7976    stevens.303@osu.edu   
Principal Investigator: Marjean T. Kulp, OD, MS         
United States, Pennsylvania
Pennsylvania College of Optometry at Salus University Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Michael Gallaway, OD    215-276-6053    mgallaway@salus.edu   
Contact: Karen Pollack    215-276-6053    kpollack@salus.edu   
Principal Investigator: Michael Gallaway, OD         
Sponsors and Collaborators
Salus University
National Eye Institute (NEI)
Marshall B. Ketchum University
Ohio State University
University of Alabama at Birmingham
State University of New York College of Optometry
Akron Children's Hospital
Nova Southeastern University
Bascom Palmer Eye Institute
Investigators
Study Chair: Mitchell Scheiman, OD Salus University
Principal Investigator: Lynn MItchell, MAS Ohio State University
  More Information

Additional Information:
Responsible Party: Mitchell Scheiman, Dean of Research, Salus University
ClinicalTrials.gov Identifier: NCT02207517     History of Changes
Other Study ID Numbers: Salus - HMS1310
U10EY022599-01A1 ( U.S. NIH Grant/Contract )
Study First Received: July 31, 2014
Last Updated: April 24, 2017

Keywords provided by Mitchell Scheiman, Salus University:
convergence insufficiency
vision therapy
reading
attention

Additional relevant MeSH terms:
Ocular Motility Disorders
Central Nervous System Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 23, 2017