PEDIG IXT7 - Intermittent Exotropia 7
Randomized trial of full-time occlusion therapy for intermittent exotropia in children.
Summary of Study
Intermittent exotropia (IXT) is a common eye condition where one or both of your eyes sometimes turn out. Long-term surgical treatment outcomes are disappointing, with high failure rates due to recurrence or undercorrection of the exodeviation. Patching is a commonly used nonsurgical treatment for which there is some evidence of short-term treatment benefit when prescribed 2-3 hours/day. The purpose of this study is to see if full-time patching can improve distance control of IXT after 3 months of treatment.
The Pediatric Eye Disease Investigator Group (PEDIG) is conducting this clinical trial to evaluate the effect of full-time patching versus no patching (observation). The study is supported through funding from the National Eye Institute of the U.S. National Institutes of Health and is being coordinated by the Jaeb Center for Health Research in Tampa, Florida.
Study specifics
- Up to 82 children to be randomized who meet the following criteria:
- 3 to less than 9 years of age
- Intermittent exotropia (IXT)
- No previous strabismus, intraocular, or refractive surgery (including Botox injection)
- No previous nonsurgical treatment for IXT (patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus)
- Not allergic to adhesive patches or silicone
- Randomly assigned 1:1 to one of two treatment groups:
- Patching full-time with occlusion dose monitor, or
- No patching, observation only
- One follow-up visit at 3 months from enrollment
How can you help?
- Your assistance is needed in referring children who are 3 to <9 years old with IXT
- Referrals can be sent to the investigator listed below
- For more information, visit the PEDIG website or call the PEDIG Coordinating Center toll free at 1-888-797-3344
Contact Information
For more information please contact:
Sherri Olsen
Clinical Research Coordinator
solsen@midwestern.edu