Many of the clinical trials performed by the Pediatric Eye Disease Investigator Group (PEDIG) have led to dramatic changes in pediatric eye care, including treatment for amblyopia, nasolacrimal duct obstruction (NLDO) and childhood strabismus.
Amblyopia treatment has been a primary focus of PEDIG, a network of pediatric ophthalmologists and pediatric optometrists that investigates common eye problems in children. Early studies identified that patching and atropine penalization were equally effective in the treatment of amblyopia in children 3-7 years of age. In addition, two hours of daily patching was found to be just as good as six hours of daily patching in the treatment of moderate amblyopia, and six hours of patching was just as good as full-time occlusion in the treatment of severe amblyopia in children 3-7 years.Positive outcomes for patients rely on proper vision and eye health screening in the medical home with proper referral.
Another study addressed whether the inclusion of near activities improved the effect of patching — it does not. Finally, good use of appropriate glasses without additional treatment was observed to improve amblyopia substantially even to the point of resolution in about 30% of children.
Results of these early PEDIG studies encourage eye care providers to start amblyopia treatment with glasses alone. Once improvement plateaus and if residual amblyopia is present, atropine or patching can be pursued as equally effective additional treatments. The burden of patching for families is lessened with prescription of fewer hours without the inclusion of near activities.
PEDIG next evaluated the response of older children to amblyopia treatment and found that many children ages 7-18 years sustained visual acuity gains after treatment, particularly if they had no prior treatment. Atropine penalization and patching are similarly effective in amblyopia treatment for children 7-12 years.
Although these studies demonstrated a surprising level of responsiveness to treatment for amblyopia in older children, a meta-analysis of PEDIG amblyopia trials has shown that children 7-13 years are significantly less responsive to treatment than children 3-5 and 5-7 years, reinforcing the need for early identification of children with amblyopia.
Currently, PEDIG is comparing a binocular game treatment of amblyopia to traditional patching in children 5-18 years (http://1.usa.gov/1pVvGYS). If the game treatment compares well to patching, this would offer families an additional amblyopia treatment.
Another area of PEDIG clinical investigation is the management of NLDO. An early study showed that nasolacrimal duct probing as a primary treatment of NLDO remains effective through age 3 (Pediatric Eye Disease Investigator Group. Ophthalmology. 2008;115:577-584). Nasolacrimal duct stent placement and balloon dacryoplasty both are effective secondary treatments for children who have residual symptoms following probing (Repka MX, et al. Arch Ophthalmol. 2009;127:633-639). A repeat probing is less effective (Pediatric Eye Disease Investigator Group. J AAPOS. 2009;13:306-307).
Children presenting with a unilateral NLDO from 6-10 months of age have a roughly two-thirds chance of spontaneous resolution in the subsequent six months (Pediatric Eye Disease Investigator Group. Arch Ophthalmol. 2012;130:730-734).
PEDIG has an ongoing interest in the management of childhood strabismus, particularly intermittent exotropia (IXT). Randomized trials comparing six months of part-time patching to observation in children 12 months to 10 years of age showed little worsening of IXT with or without treatment in this timeframe. Observation of these children for 36 months will provide additional natural history data regarding IXT. A study comparing two surgical managements of IXT is ongoing, and a protocol evaluating a spectacle treatment for IXT is under development.
Other areas of interest for PEDIG include childhood cataract, pediatric optic neuritis, esotropia and refractive surgery for children with high refractive errors and amblyopia.
Positive outcomes for patients rely on proper vision and eye health screening in the medical home with proper referral of children as outlined in Procedures for the Evaluation of the Visual System by Pediatricians (www.pediatrics.org/cgi/doi/10.1542/peds.2015-3597), a joint clinical report from the Academy, American Academy of Ophthalmology, American Association of Pediatric Ophthalmology and Strabismus, and American Association of Certified Orthoptists.
Dr. Lee is a member of the AAP Section on Ophthalmology and vice chair of the Pediatric Eye Disease Investigator Group.