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Key components in retinopathy of prematurity trials include risk factors, predictive models, telemedicine and tele-education trends, and treatment.
Reviewed by R.V Paul Chan, MD
Clinical trials have helped pediatric ophthalmologists and retina specialists make strides in identifying risk factors and predictive models for retinopathy of prematurity (ROP) as well as treatments, said R.V. Paul Chan, MD.
“Historically, the trial of Cryotherapy for Retinopathy of Prematurity [CRYO-ROP] and Early Treatment in Retinopathy of Prematurity [ETROP] Study have provided much of the data we use to guide the management of ROP,” said Dr. Chan, professor of ophthalmology and director, Pediatric Retina and Retinopathy of Prematurity Service, Illinois Eye and Ear Infirmary at the University of Illinois, Chicago.
“With the advent of ROP predictive models, telemedicine, and anti-vascular endothelial growth factor [VEGF] treatments, the way we are managing it is rapidly evolving,” he added.
Dr. Chan mentioned several trials have analyzed ROP predictive models, including WINROP2, CHOP-ROP, e-ROP, CO-ROP, and i-ROP. Some factors analyzed in these trials have included gestational age, birth weight, weight gain, imaging informatics, and genetic factors.
For the most part, the goal of predictive models is to improve the identification of children at risk for certain categories of ROP and reduce the number of screening examinations, Dr. Chan said.
“Even though the results of these studies are promising, we have to keep in mind that all of these models need to be tested rigorously,” he said. “And currently, none of these models is accepted universally for clinical care.”
Another area explored through ROP trials is telemedicine. Dr. Chan specifically mentioned the National Institutes of Health EROP study.
“A key finding in the study is that non-physician readers may do well in identifying referral-warranted ROP, and it will be important to understand the implications of this in real-world telemedicine programs that are not part of a study,” he said.
Dr. Chan also mentioned a number of active telemedicine programs from around the globe, including ROPE-SOS and KIDROP (both in India) and SUNDROP in the United States.
Tele-education is another area explored in trials that has the potential to improve access to care.
Dr. Chan mentioned GENROP, which has shown how web-based platforms can improve diagnostic accuracy. He also mentioned imaging techniques, such as fluorescein angiography and digital mosaic imaging-both of which can improve diagnostic accuracy and inter-reader agreement.
The use of computer-based image analysis has a growing potential role in ROP diagnosis. Both the i-ROP system and ROPTool have been found to have good accuracy for the detection of vascular abnormalities suggestive of plus disease when compared with expert physician graders, he noted.
Dr. Chan also addressed how anti-vascular endothelial growth factor (VEGF) treatment has been used for ROP care for a number of years. This includes several studies, such as BEAT-ROP, which focused on bevacizumab; and the prospective, international RAINBOW study, with a focus on ranibizumab compared with laser therapy. The follow-up that is part of the RAINBOW study will be important to help with the understanding of ROP recurrence and track any long-term adverse events, he explained.
In the BEAT-ROP study, Dr. Chan noted it is not surprising to find that children treated with the laser were found to have more high myopia than those who received anti-VEGF treatment. Regarding recurrence in BEAT-ROP, infants initially treated for aggressive posterior ROP appeared to have a significantly higher risk of recurrent disease.
In addition, Dr. Chan presented data from the i-ROP group demonstrating that treatment may be indicated in some patients with less than type I ROP.
R.V. Paul Chan, MD
This article was adapted from Dr. Chan’s presentation at the 2016 meeting of the American Academy of Ophthalmology. Dr. Chan is a consultant for Alcon Laboratories, Allergan, Bausch + Lomb, and Visunex Medical Systems.