Status:
TERMINATED
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
32-40 years
Brief Summary
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 o...
Detailed Description
Study Design: Observational Cohort Study Setting/Participants: Premature babies who are at high risk for ROP during their stay in the neonatal intensive care unit (NICU). * The number of sites - 5 ce...
Eligibility Criteria
Inclusion
- Babies with birth weights of \<1251g
- Babies having clinical examinations to screen for ROP
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 16 2016
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT02257307
Start Date
July 1 2014
End Date
March 16 2016
Last Update
April 13 2017
Active Locations (5)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
2
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Vanderbilt University
Nashville, Tennessee, United States, 37232