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

NCT ID: NCT02207517

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2020-11-30

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 Description

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 be randomized to 16 weeks of treatment with either [a] office-based vergence/accommodative therapy with home reinforcement (OBVAT) or [b] office-based placebo therapy with home reinforcement (OBPT). Outcomes (reading and attention) will be assessed after 16 weeks of treatment. In addition, we will test the long-term effects on outcomes at 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups.

Specific Aim 1 - Reading Performance: To compare reading comprehension outcomes for children with symptomatic CI who receive 16 weeks of OBVAT and OBPT treatment. The primary outcome measure of reading performance is the Wechsler Individual Achievement test (WIAT-III) reading comprehension subtest score. In secondary analyses, we will examine the effects of the treatment on word reading, pseudoword decoding, oral reading fluency, and listening comprehension. We also will examine the correlation of changes in CI symptoms and ophthalmic signs with reading outcomes. Analysis of the 1-year follow-up data will be used to determine if any gains in reading performance observed after 16 weeks of treatment are sustained.

Specific Aim 2 - Attention: To investigate the effect of treatment on teacher- and parent-rated measures of attention for children with symptomatic CI who receive 16 weeks of OBVAT and OBPT intervention. The primary outcome measure of attention is the score on the Strengths and Weaknesses of ADHD Symptoms and Normal Behavior Scale (SWAN). In secondary analyses, we will examine the effects of treatment on a second parent-rated attention scale called the SNAP. We also will examine the correlation of changes in CI-symptoms and ophthalmic signs with attention outcomes. Analysis of the 1-year follow-up data will be used to determine if any gains in attention observed after 16 weeks of treatment are maintained.

Scientific and Clinical Impact: The relationship between the treatment of symptomatic CI and its effect on reading and attention in children is unknown. The results of the proposed study will contribute to a better understanding of these relationships and help to resolve controversy surrounding this issue. The results will have important implications for educators, psychologists, eye professionals, and other health care providers who care for children with reading and attention problems and guide hypothesis development for future scientific investigations on evidence-based relationships between visual disorders and other developmental disorders in children.

Conditions

Convergence Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Office-based vergence/accommodative therapy

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Office-based vergence/accommodative therapy

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Vision Therapy; Orthoptics

Eligibility 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Marshall B. Ketchum University

UNKNOWN

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

State University of New York College of Optometry

OTHER

Sponsor Role: collaborator

Akron Children's Hospital

OTHER

Sponsor Role: collaborator

Nova Southeastern University

OTHER

Sponsor Role: collaborator

Bascom Palmer Eye Institute

OTHER

Sponsor Role: collaborator

Salus University

OTHER

Sponsor Role: lead

Responsible Party

Mitchell Scheiman

Dean of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitchell Scheiman, OD

Role: STUDY_CHAIR

Salus University

Lynn MItchell, MAS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

University of Alabama, Birmingham College of Optometry

Birmingham, Alabama, United States

Southern California College of Optometry Marshall B. Ketchum University

Fullerton, California, United States

NOVA Southeastern University College of Optometry

Fort Lauderdale, Florida, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

State University of Optometry College of Optometry

New York, New York, United States

Akron Children's Hospital

Akron, Ohio, United States

Ohio State University College of Optometry

Columbus, Ohio, United States

Pennsylvania College of Optometry at Salus University

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33771952 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33263359 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31651592 (View on PubMed)

Other Identifiers

U10EY022599-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Salus - HMS1310

Identifier Type: -

Identifier Source: org_study_id