Ophthalmology Clinical Research

Clinical researchers at Nationwide Children's and The Ohio State University are committed to identifying new approaches for the prevention, diagnosis and treatment of childhood diseases, taking research discoveries from the lab to the patient's bedside.

To see current Ophthalmology clinical studies being conducted at Nationwide Children's Hospital and The Ohio State University, search the options below.

Bevacizumab Treatment for Severe ROP

What is ROP?

Retinopathy of prematurity (ROP) is a disease in which the blood vessels inside the eye do not grown the way they should.

What is the Purpose of This Study?

The purpose of this study is to find a dose of Bevacizumab (trade name Avastin) that is lower than currently used for severe (type 1) ROP. The lowest effective dose that is identified in this trial will be tested in future larger studies. Avastin has not been approved by the Food and Drug Administration for ROP. Its use is considered experimental.

What Will Happen During the Study?

If your infant is in the study, he or she will have one injection of Avastin. If both of your infant’s eyes need treatment for ROP, a computer program will decide which eye gets the study dose of Avastin. Using a computer this way is like flipping a coin. The study dose of Avastin is the amount of medication that is currently being tested in the study. The injection will be done through a small needle after your infant receives anesthesia.

Here is a list of study visits:

  • Visit 1: 1 day after injection (If persistent ROP is noted, more frequent exams may be needed)
  • Visit 2: 1 week (6 to 8 days) after injection
  • Visit 3: 2 weeks (12 to 16 days) after injection
  • Visit 4: 3 weeks (19 to 23 days) after injection
  • Visit 5: 4 weeks (26 to 30 days) after injection
  • Visit 6: 12 months corrected (your due date plus 12 months)

At each exam, the eye doctor will check your infant’s eyes to make sure that the ROP has responded to treatment.

Who can I Contact for More Information?

Contact study coordinator Amanda Schreckengost at (614) 722-4080.

CTX: Prevalence of Cerebrotendinous Xanthomatosis in Patients Diagnosed with Early-Onset Idiopathic Bilateral Cataracts

What is Cerebrotendinous Xanthomatosis (CTX)?

CTX is a progressive disease in which the body does not make bile acids normally.

Symptoms that can be associated with CTX:

  • Chronic diarrhea
  • Tendon xanthomas
  • Neurological problems
  • Juvenile idiopathic bilateral cataracts.

What is the Purpose of This Study?

This study aims to help researchers learn more about the prevalence (commonness) and symptoms of cerebrotendinous xanthomatosis (CTX). People with early-onset idiopathic bilateral cataracts, which refers to cataracts in both eyes (bilateral) that started at a young age (early-onset) without any clear cause (idiopathic) may be eligible for the study. This study is observational, meaning there is no investigational study medication or treatment being tested or given to participants; the study is only being done to help researchers learn more about CTX.

What Will Happen During the Study?

If you qualify for and choose to participate in this study, you will be in the study for a total of eight weeks. All study-related tests and evaluations will be provided to you at no cost. If it is determined that you have or may be at risk for CTX, the study doctor will provide you with more information and referrals for appropriate follow-up care.

Study participation includes:

  1. A visit with the study doctor to perform the very simple study tests and procedures, which include reviewing your medical history and taking one urine sample and once blood sample to test for the gene that causes CTX. In most cases, these procedures will all be done in one visit, but an extra visit may be required to collect a blood sample if one cannot be taken at the original visit date.
  2. A follow-up phone call with the study doctor about eight weeks later to discuss the results of your blood and urine tests and address any questions you may have.

Who can I Contact for More Information?

To learn more about this study or to see if you may be eligible, visit www.CataractsStudy.com. You may also contact the Study Coordinator Amanda Schreckengost at (614) 722-4080.

"Dig Rush" Binocular Game Treatment for Amblyopia

What is Amblyopia?

Amblyopia is a disorder of sight that results in decreased vision in an eye that otherwise typically appears normal.

What is the Purpose of This Study?

“Dig Rush” is a new binocular game played on an iPad used as a binocular approach to treating amblyopia without patching, atropine drops or blurring filters. The purpose of this study is to investigate whether binocular treatment is an effective treatment for amblyopia in children 4 to <13 years of age.

What Will Happen During the Study?

If you agree to have your child take part in the study, a computer program will determine whether your child will receive binocular treatment with spectacles or continued spectacle correction only. This is similar to flipping a coin. Children who are in the spectacle correction only group will have the opportunity to receive the binocular treatment at the end of the study. Participants in the binocular treatment group will receive an iPad to play “Dig Rush” at home.

To allow your child to take part in the study, you must be willing to bring your child to the following sessions:

  • Initial visit to see if your child is eligible
  • Follow-up visit 4 weeks from initial visit
  • Follow-up visit 8 weeks from initial visit
  • If you are in the spectacle correction only group and would like your child to receive binocular treatment there will be an additional follow-up visit 16 weeks from initial visit.

You will also need to ensure that your child performs the prescribed home treatment.

Who can I Contact for More Information?

Contact study coordinator Amanda Schreckengost at (614) 7220-4080.

A Randomized Trial of Levodopa as Treatment for Residual Amblyopia

Purpose of study:

The purpose of this study is to treat amblyopia that has not responded to treatments in the past (including patching and eye drops).

Who can participate:

Children 7 to 12 years of age

What will happen during the study:

Amblyopia is usually treated with a patch or with eye drops in the good eye; forcing the child to use the weak eye. When this treatment does not cure the amblyopia, some doctors have used a drug called levodopa along with patching of the good eye to treat amblyopia. Levodopa is changed in the body to a chemical called dopamine. Dopamine is thought to have a role in how we see. It works both in the eye and in the brain. It is thought that increasing the dopamine by giving levodopa might improve vision in amblyopia. Levodopa is taken in a capsule by mouth. This study will see if taking levodopa while wearing a patch over the good eye for 2 hours/day can make amblyopia better. It will compare the levodopa group with a smaller group using placebo.

Who to contact:

Study Coordinators Amy Wagner (614.224.6222) and Rae Fellows (614.722.4080)

ClinicalTrials.gov
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