Treatment of TBI-Induced Oculomotor Dysfunction and Associated Reading Problems

Principal Investigator: Kenneth J. Ciuffreda, OD, PhD
Co-Principal Investigator: Jose Capo-Aponte, OD, PhD

Co-investigators:
Neera Kapoor, OD, MS (clinical coordinator)
Preethi Thiagarajan, OD (graduate student researcher)
Diana Ludlam, BS (certified vision therapist)

Why we are doing this study:

There are clinical evidence and some research studies indicating the strong benefits of vision therapy for persons with mild traumatic brain injury (mTBI) who are visually-symptomatic with ocular motor (eye movement) deficits and associated reading problems.

Our study compares the effects of 6 consecutive weeks of computerized oculomotor (eye movement) training to that of 6 consecutive weeks of computerized SHAM training. SHAM training employs a series of eye movement/ eye focusing lenses and procedures, which are similar to the proposed experimental therapy lenses and procedures, but have no known therapeutic effect. Each subject will receive the (presumed) oculomotor training, as well as the SHAM training, but will not be informed which type of training is being received during the study period.

Who can be in the study:

We plan on investigating the effects of eye movement therapy for those:

1) with mTBI (1 to 10 years post-injury)

2) between 18 and 40 years of age

3) are visually symptomatic with intermittent eyestrain, blurred vision, loss of place when reading/slower reading speed/skipping lines when reading)

4) with the appropriate cognitive capacity to understand the examiner’s instructions for various training tasks

5) with stable general health, aside from the mTBI itself.

6) with sufficient clarity of vision (20/30 or better in the poorer-seeing eye)

7) with no evidence of ocular disease for either eye

8) not taking medications, which impact eye movements or clarity of vision

What the study involves:

We investigate the efficacy of providing eye movement therapy for those with mTBI who are visually-symptomatic with eye movement symptoms and associated negative impact on reading. The eye movement therapy (one of: SHAM or presumed) will occur twice weekly for 6 weeks and then the other eye movement therapy will occur twice weekly for 6 weeks. The primary outcome measure will be objective recordings of eye movements on 5 occasions:
1) pre-vision therapy (i.e., baseline)

2) after the first 6 weeks of eye movement therapy

3) after the second 6 weeks of eye movement therapy

4) 3 months post- eye movement therapy

5) 6 months post- eye movement therapy

Will you directly benefit from the study?

Being in this study will not benefit participants directly.

You will receive $300 as monetary reimbursement for your time and transportation after completing Week 15 (which corresponds to the 3 weeks of testing and 12 weeks of training), with the remaining $200 of your monetary reimbursement being given upon completion of the 6-month follow-up re-evaluation session.

You will not be required to pay for any research-related tests.

You may withdraw from the study at any time and without any inducement to complete the testing and training program. If you wish to withdraw from the study prior to its completion, you will be reimbursed financially on a prorated basis ($12/session) for the number of sessions completed.

For more information, contact the Clinical Vision Research Center.