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

NCT02207517 | Unknown Phase 3 DMC

• 2 other identifiers: Salus - HMS1310U10EY022599-01A1
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 8

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

Conditions

Convergence Insufficiency

Keywords

convergence insufficiency; vision therapy; reading; attention

Outcome Measures

Primary Outcomes (1)

• 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).

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

  After 16 weeks of treatment

Secondary Outcomes (5)

• The change in the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN)

  After 16 weeks of treatment

• Gates-McGintie 4

  After 16 weeks of treatment

• d2 Test of Attention

  After 16 weeks of treatment

• Academic Behavior Survey (ABS)

  After 16 weeks of treatment

• Curriculum Based Measurement (CBM)

  After 16 weeks of treatment

Study Arms (2)

Office-based verg/accomm therapy (OBVAT)

EXPERIMENTAL

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

Office-based placebo therapy (OBPT)

PLACEBO COMPARATOR

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

Interventions

Office-based vergence/accommodative therapy PROCEDURE

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

Also known as: Vision Therapy, Orthoptics

Office-based placebo therapy (OBPT); Office-based verg/accomm therapy (OBVAT)

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 9 to less than 14 years
• Grades 3 through 8
• CI Symptom Survey (CISS) score greater or equal to 16
• Exophoria at near at least 4 prism diopters greater than at far
• Receded near point of convergence (NPC) of 6 cm or greater break
• Insufficient positive fusional vergence (PFV) at near (i.e., failing Sheard's or PFV less than or equal to 15 BO break)
• Best-corrected distance visual acuity of 20/25 or better in each eye
• Random dot stereopsis appreciation of 500 seconds of arc or better
• 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

You may not qualify if:

• Constant strabismus at distance or near
• Esophoria of greater than or equal to 2∆ at distance
• Vertical heterophoria greater than or equal to 2∆ at distance or near
• greater than or equal to 2 line interocular difference in best-corrected distance visual acuity
• Monocular near point of accommodation greater than 20 cm (accommodative amplitude less than 5D) in right eye
• Manifest or latent nystagmus
• Word Reading subtest score less than 80 on the Wide Range Achievement Test (WRAT-4)
• Kaufman Brief Intelligence Test (KBIT-2) Matrices subtest score less than 70
• History of prior strabismus, intraocular, or refractive surgery
• CI previously treated with any form of office-based vergence/accommodative therapy or home-based vergence therapy (e.g., computerized vergence therapy)
• CI associated with head trauma or known disease of the brain
• Diseases known to affect accommodation, vergence, or ocular motility
• Inability to comprehend and/or perform any study-related test or therapy procedure
• Speech-language disorder (e.g., stuttering) that would interfere with interpretation of digital recordings of reading tests
• Significant hearing loss

Sponsors & Collaborators

• Salus University: lead
• National Eye Institute (NEI): collaborator
• Marshall B. Ketchum University: collaborator
• Ohio State University: collaborator
• University of Alabama at Birmingham: collaborator
• State University of New York College of Optometry: collaborator
• Akron Children's Hospital: collaborator
• Nova Southeastern University: collaborator
• Bascom Palmer Eye Institute: collaborator

Study Sites (8)

University of Alabama, Birmingham College of Optometry

Birmingham, Alabama, 35294, United States

Location

Southern California College of Optometry Marshall B. Ketchum University

Fullerton, California, 90037, United States

Location

NOVA Southeastern University College of Optometry

Fort Lauderdale, Florida, 33314, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

State University of Optometry College of Optometry

New York, New York, 10036, United States

Location

Akron Children's Hospital

Akron, Ohio, 44302, United States

Location

Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Pennsylvania College of Optometry at Salus University

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (3)

• CITT-ART Investigator Group. Effect of Vergence/Accommodative Therapy on Attention in Children with Convergence Insufficiency: A Randomized Clinical Trial. Optom Vis Sci. 2021 Mar 1;98(3):222-233. doi: 10.1097/OPX.0000000000001659.

  PMID: 33771952 DERIVED

• Scheiman M, Kulp MT, Cotter SA, Lawrenson JG, Wang L, Li T. Interventions for convergence insufficiency: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 2;12(12):CD006768. doi: 10.1002/14651858.CD006768.pub3.

  PMID: 33263359 DERIVED

• CITT-ART Investigator Group. Effect of Vergence/Accommodative Therapy on Reading in Children with Convergence Insufficiency: A Randomized Clinical Trial. Optom Vis Sci. 2019 Nov;96(11):836-849. doi: 10.1097/OPX.0000000000001442.

  PMID: 31651592 DERIVED

MeSH Terms

Conditions

Ocular Motility Disorders

Interventions

Orthoptics

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mitchell Scheiman, OD

  Salus University

  STUDY CHAIR

• Lynn MItchell, MAS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Research

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

US (8)