The Underlying Neural Mechanism of VT for Patients with CI: Patient Recruitment


In Part 1 we introduced you to the interdisciplinary collaborative research in VT that is occurring through the New Jersey Institute of Technology and the Pennsylvania College of Optometry at Salus University.  The collaborative project is in its active recruitment phase.

 

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Toward that end,  the following letter provides the details for patient recruitment.

December 7, 2016

Dear Colleague,

We would greatly appreciate your help with patient recruitment.

Tara Alvarez, PhD is funded by the National Eye Institute to study the underlying neural mechanism of vision therapy for patients with convergence insufficiency (CI), and I am helping her with the clinical aspects of the study. As you may know, I have been trying to improve the quality of our research for 2 decades and we have made much progress. However, there is more work to be done and I can tell you that the results of this NEI-funded study have the potential to move us to the next level of discovery about CI. Dr. Alvarez had designed a study that should help answer the question of not only if VT is effective for CI, but how and where in the brain those changes actually occur. The study is also designed to look at mechanistic changes in vergence and accommodation that go way beyond the typical results of clinical trials.

We are recruiting young (ages 18 to 35) adults with symptomatic CI. When we enroll a subject, I perform the clinical testing and then other investigators in the lab perform objective recordings of vergence, accommodation and saccades. Finally the subject has an fMRI. After this initial testing they are randomized into either office-based VT or office-based placebo therapy for twelve weeks. At the end of the treatment, all of the initial testing is repeated. We have NJIT and Rutgers Institutional Review Board Certification. The benefit for you is that you will be helping science to establish the scientific based data of how vision therapy is changing the brain to lead to a long term reduction in vision symptoms for those with CI. This knowledge and the additional sub-aims of this study promise to dramatically advance our knowledge of VT and provide support for the use of vision therapy/rehabilitation. The implications will be broad and may help change the opinions of those who might still be skeptical about the effectiveness of vision therapy.

The benefits to your CI patients are as follows:
Receive 12 weeks of office based vergence and accommodative therapy at no cost to them.
If they are assigned to the placebo treatment arm then they do have the opportunity to receive active treatment after the post assessment measurements are completed.
Receive $450 for their participation which includes transportation cost.
Help with science to establish evidence based data to understand how vision therapy works.

The whole study takes about 25 sessions of about 1 hour each where the research team works with the patient’s schedule. These sessions are located on NJIT campus in University Heights, Newark, NJ. The study is composed of the following:

Baseline Measurements:
2 functional imaging session
Clinical exam that I conduct
3 eye movement recording sessions
12 one -hour vision therapy sessions
Post Assessment Measurement:
1 functional imaging session
Clinical exam that I conduct
3 eye movement recording sessions

The inclusion / exclusion criteria are the following:

Eligibility/Inclusion criteria Exclusion Criteria for all Subjects:
Age 18-35 years (non-presbyopic with an adult visual system opposed to pediatric developing system). Previous office- or home-based vision therapy, orthoptics, home-based near-target push-ups, or pencil push-ups.
Best-corrected visual acuity of 20/25 in both eyes at distance and near. Amblyopia or constant strabismus or strabismus surgery.
Willingness to wear glasses or contacts to correct refractive error, if needed. Prior refractive surgery.
Stereopsis of 500 sec arc using Randot Stereo Test.
CIs will be symptomatic (CISS > 21)

1: Exophoria at near at least 4Δ > than at distance.

2: Reduced PFV at near ≤ 15 Δ.

3: NPC of ≥ 8 cm break).

Acquired Brain Injury. Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves’ thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).

Any medication known to affect accommodation or vergence.

Near point of accommodation >20 cm.
Vertical heterophoria greater than 1Δ.
Any eye care professional or multiple people from the same household participating in study.

CISS = convergence insufficiency symptom survey; PFV = positive fusional vergence; NPC = near point of convergence

 

Thank you for your time and consideration on this very important study! If you know of a patient who is interested, please have him/ her contact:
Tara Alvarez, PhD
Professor Biomedical Engineering
Email: tara.l.alvarez@njit.edu

Sincerely,
Mitchel Scheiman, O.D., Ph.D.
Professor 
Dean of Research
Director of Graduate Programs
Salus University
Pennsylvania College of Optometry
8360 Old York Rd
Elkins Park, PA 19027

salus

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