March 22, 2012
Thanks to the efforts of Iris Kassem, MD, PhD, Assistant Professor of Ophthalmology, the Pediatric Ophthalmology and Adult Strabismus Service was recently approved for membership in the Pediatric Eye Disease Investigator Group (PEDIG). Partnering with this international group translates into more opportunities for UIC to participate in important clinical research.
PEDIG is a collaborative network that facilitates multicenter clinical research in strabismus (crossed or wandering eyes), amblyopia (lazy eye) and other pediatric eye disorders. Formed in 1997, PEDIG is funded by the National Eye Institute, which is part of the government’s National Institutes of Health that supports medical research. PEDIG currently has over 100 participating sites (offices) in its network, with more than 250 pediatric ophthalmologists and optometrists in the U.S., Canada and the United Kingdom. The network includes not only academic institutions, but private practice physicians as well.
“I remember hearing about the network in medical school and thinking that this would be something I would want to participate in because it’s a collaborative effort of clinical research with the goal of using evidence-based medicine to improve pediatric eye care,” recalls Dr. Kassem.
Dr. Kassem explains that PEDIG’s studies are designed by its members and carefully thought-out in both committee and open group formats.
“This allows the studies to be designed and critiqued by multiple sources, often answering or addressing many of the confounding questions prior to initiating the study,” notes Dr. Kassem.
Dr. Kassem adds that PEDIG tends to do prospective studies, which are a better format than the retrospective studies that are commonly done. In addition, the large number of sites makes patient recruitment quicker than “going it alone.”
The PEDIG team at UIC includes Dr. Kassem and Nathalie Azar, MD, Director of Pediatric Ophthalmology and Adult Strabismus Service. Also on the team are Alexander Khammar, MD, and Benjamin Ticho, MD, who are PEDIG investigators in private practice and see patients at UIC. Initially the team will be doing studies on refractive errors and glasses in children, strabismus and pediatric cataract surgery.
The first study, which is expected to start in the spring and is now open for enrollment at certified PEDIG sites, is HTS1 – Glasses versus Observation for Moderate Hyperopia in Young Children. This study will help pediatric ophthalmologists determine whether it is better to give glasses to asymptomatic children with a moderate level of hyperopia (farsightedness) for the development of vision and prevention of amblyopia and strabismus, or if glasses therapy can be delayed.
“It’s clear that children with a low degree of hyperopia without strabismus don’t need glasses, and a higher degree will have amblyopia and possibly strabismus,” notes Dr. Kassem. “But it’s difficult to define what should be done in that middle range.”
Soon after starting the HTS1 study, Dr. Kassem says that UIC plans to begin a surgical clinical trial called IXT1. Patients will be randomized into one of two groups, and will undergo surgical correction of intermittent exotropia (a form of strabismus in which the eyes are deviated outward, also known as IXT) on either two muscles in one eye or one muscle in each eye. The study will investigate whether there is an advantage in one- versus two-eyed surgery.
“Intermittent outward drifting of the eyes is often observed in our patients,” says Dr. Kassem. “ But if the control is poor or the patient loses the ability to look with both eyes together (stereopsis), surgery may be indicated.”
Finally, the UIC team plans to participate in the pediatric cataract surgery registry study, C02, which is a prospective monitoring of patients who have had cataract surgery.
“This is purely an observational study that will help determine future clinical trials that may answer questions in our children with childhood and infantile cataracts,” notes Dr. Kassem.