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

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.

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