PEDIG Intermittent Exotropia Study (IXT5)
Why we are doing this study:
The Intermittent Exotropia Study (IXT5) is a study for children who have intermittent exotropia, a condition where an eye turns outward some of the time and at other times both eyes are straight. We are trying to find out if using glasses with special lenses (overminus glasses) can be used as a treatment for this condition.
Who can be in the study:
- Children aged 3 to 10 years with intermittent exotropia (IXT)
- No treatment for IXT in the past 4 weeks (except with glasses or contact lenses only)
- No treatment using over-minus glasses in the past 6 months, and no previous eye muscle surgery
Specific screening questions will be asked before scheduling a study appointment.
What the study involves:
There are five office visits over the course of 18 months, each taking approximately 1-2 hours. At the end of the first study visit, if they are eligible, your child will be randomized (like the toss of a coin) to receive either overminus glasses or non-overminus glasses. You will not know what kind of glasses they have been assigned to receive and our staff will not be allowed to tell you until the end of the study.
Follow-up visits will occur at 6, 12, 15 and 18 months. New glasses or replacement lenses will be provided at the end of the eligibility, 12 month, and 15 month visits.
Will you directly benefit from the study?
There may or may not be a benefit to your child by being in the study, but there is no guarantee.
Other things you should know about the study:
- Parental consent is required to participate in this study