NOVARTIS STUDY

For Amblyopia (Lazy Eye)

This Study is CLOSED to Enrollment!

Reason for Study
In recent years, a different type of research treatment for amblyopia has been tried called dichoptic training.  This is still being studied to see how effective it is to treat lazy eye conditions.  Dichoptic training involves giving visual information to both the lazy eye and non-lazy eye simultaneously, but differently, to try to get the lazy eye to work better.  If the research results are positive, this may be used as an alternative to traditional therapy, such as patching.

Why is this important
Amblyopia is one of the most common causes of vision loss in the United States and elsewhere.  Current treatment with patching or eye drops is often poorly tolerated by children and therefore not done.

Who is eligible
Participation is voluntary. The study is currently enrolling children ages 4-12 years (8-12 year old group is now full). Children must have a certain level of amblyopia and vision in their better seeing eye to qualify.  They must also not have had more than 1 year of prior amblyopia treatment.  They must also be able to play 2 video games at a specified level.  There are certain other criteria that would be determined during a screening exam.

Will my child benefit
This benefit is unknown and is being investigated with the study. The study is to determine the safety and effectiveness of this treatment.  Your child will not be doing other amblyopia treatment during the initial 8-16 week treatment period of this study.
How long is the study and what is involved

Your child ages 4-7 years will be randomly selected to either play video games on a Samsung tablet with special glasses for 1 hour per day or to wear a patch for 2 hours a day.  The duration of therapy will be between 8-12 weeks of video game play or 16 weeks of patching.  There will be a total of 8 -9 visits (one of which will be a phone call) visits over 52 weeks involved in the study.

Children in the 8-12 year age group will be asked to play video games on a Samsung tablet with special glasses for 1 hour per day for 8 weeks.  There will be 7-8 visits (2 of which will be phone calls) over 52 weeks for the study.

There is no charge for the visits done as part of the study. There is some compensation for your time and travel involved in study participation.

If you have a child who has amblyopia and you wish to consider participation in this study, please contact Tanja at 407-767-6411 ext. 239

Principal Investigator: Dr. Louis C. Blumenfeld
Sub-investigators: Dr. Robert Gold, Dr. Andrew Schneier, Dr. Justin Marsh

407-767-6411
Serving Central Florida areas not exclusive to Orlando, Maitland, MetroWest, Winter Park, Lake Mary, Oviedo.
Central Florida Counties: Orange and Seminole County

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