Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

Stopped early

Conditions studied: Retinopathy of Prematurity

In brief

Evaluating retinopathy of prematurity (eROP) ancillary study Implementation Project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the Clinical Center.

Key facts

Study ID

NCT02257307

Run by

Children's Hospital of Philadelphia

People needed

244

Starts

2014-07-01

Expected to finish

2016-03-16

Last updated by the study team

2017-04-13

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Babies with birth weights of <1251g
• Babies having clinical examinations to screen for ROP

You may not qualify if…

• Referral from an outside hospital for treatment of serious ROP that is performed before imaging can be obtained.
• Congenital Non-ocular Anomalies: Babies will be excluded from this study if they have a severe congenital non-ocular anomaly. Such exclusions include anencephaly, trisomy 13, trisomy 18, or severe cardiac or pulmonary abnormalities. The neonatologist caring for the baby will determine whether a particular congenital abnormality would exclude the baby from participation in this study.
• Ocular Abnormalities: Babies will be excluded from this study if they have major congenital abnormalities in one or both eyes including microphthalmos, anophthalmos, anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma, chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. Eyelid abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely affect vision, would also exclude a baby from participation. Minor abnormalities that would not be expected to affect vision may not be exclusion criteria including Mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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