PEDIG | CITS
Why we are doing this study:
This is a study for children age 9 years to less than 18 years old who have convergence insufficiency (CI). Convergence insufficiency is an eye problem where the eye turns out when reading or doing close work. Children with this eye problem may have pain in their eyes, blurry or double vision, headaches, and other problems when reading and doing close work.
This study will look at two active treatments for CI that can be done at home. These treatments will be compared to a treatment that is not active. We want to find out which active treatment works best and if either is better than using a non-active treatment.
Who can be in the study:
Children age 9 years to less than 18 years with CI.
What the study involves:
Children can participate in this study after they have had an eye exam at our center to check their eye condition.
In this study, participants:
- will be put into 1 of 3 treatment groups.
- Active therapy with computer software and control therapy with hand-held equipment;
- Active therapy with hand-held equipment and control therapy with computer software;
- Control therapy with computer software and control therapy with hand-held equipment
- will need to do the treatment for 20 minutes a day, 5 days a week, for at least 12 weeks.
- will not know what treatment they get until they finish the study.
- will come back for a check-up at 6 and 12 weeks after starting the study.
If participants’ eye problems do not go away by 12 weeks, they will be done with the study. Participants will be allowed to keep the home-based computer program and/or active hand-held materials.
If participants’ eye problems go away by 12 weeks, the doctor will stop treatment. The doctor will then see the participant again after 6 months.
Will you directly benefit from the study?
Being in this study might correct your child’s CI. You will receive $40 for each visit for your time for the study.
Other things you should know about the study:
- Parental permission is required for minors (under age 18) to participate in this study, so a parent will need to be present during the enrollment visit.
Principle Investigator: Robert Duckman
For more information, contact the Clinical Vision Research Center.