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    Digital imaging screening may identify infants with referral-warranted ROP

    Telemedicine system could decrease number of unnecessary exams, identify children who need treatment

     

    Twelve North American centers participated in the study. Infants were enrolled and eligible for ROP examinations if birth weight was less than 1,251 grams. Of the 1,284 enrolled infants, 1,257 had ROP examinations. The mean birth weight was 864 grams, and the mean gestation age was 27 weeks. Of this group, 51% were males, 56% were Caucasian, and 29% were black. Investigators found 63.7% of these infants had some degree of ROP, and 19.4% (244 infants) had referral-warranted ROP.

    When investigators looked at the rate of referral-warranted ROP by gestational age, they found “as expected, that the rate of referral-warranted ROP decreased in incidence [by] increasing gestational age,” Dr. Quinn said.

    For example, at one end of the spectrum, 63% of 83 patients with a gestational age of 23 weeks or less had referral-warranted ROP, whereas 7.8% of 204 patients with a gestational age of 27 weeks had referral-warranted ROP. Only one infant with a gestational age over 29 weeks had referral-warranted ROP.

    Study procedures were as follows. After enrollment, babies underwent serial diagnostic examinations by an ophthalmologist and retinal imaging (RetCam Shuttle, Clarity Medical Systems) by non-physician imagers; clinical data and images were uploaded to a central server; and trained non-physician readers graded the images. ROP-expert readers also graded a subset of images.

    An array of clinical staff included certified retinal imagers; namely, ophthalmic photographers, neonatal nurse practitioners, neonatal intensive-care nurses, optical coherence tomography technicians, certified ophthalmic medical technicians, and ophthalmic technologists.

    At the reading center, three trained non-physician readers, three expert readers who were ophthalmologists, and one ophthalmologist reading center adjudicator were involved.

    To assess the effectiveness of the telemedicine system, all images from infants with referral-warranted ROP and from randomly selected infants without ROP were graded—i.e., a total of 5,520 image sets from 855 infants. Two trained non-physicians readers graded the images. The reading center adjudicator settled any discrepancies.

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