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Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

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ClinicalTrials.gov Identifier: NCT02257307
Recruitment Status : Terminated (expired study)
First Posted : October 6, 2014
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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 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.

Condition or disease Intervention/treatment
Retinopathy of Prematurity Procedure: RetCam retinal imaging used for routine care

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 centers in the US
  • The number and description of participants: 500 babies with birth weights of <1251g

Study Interventions and Measures:

Data from RetCam digital images obtained as part of clinical care during the routine diagnostic eye exam for ROP will be uploaded and transmitted via secure server to a central reading center. These de-identified images will be graded by Certified Image Readers. Results of image gradings will be sent back via secure web-based platform to the Clinical Center. The primary outcome measure is the turnaround time from uploading the images to feedback to the Clinical Center. The secondary outcome measure is the time required to obtain retinal images for babies scheduled for ROP examination in the NICU (relative cost-effectiveness).


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Study Type : Observational
Actual Enrollment : 244 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Ancillary Study - Implementation Project
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : March 16, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: RetCam retinal imaging used for routine care
    De-identified digital images of both eyes, obtained by a non-physician Certified ROP Imager (CRI) using the RetCam Shuttle, will be uploaded to the secure server for remote evaluation by a Trained Reader. The results of the Reader's evaluation will be reported to the Clinical Center.


Primary Outcome Measures :
  1. Determine whether imaging evaluation can be achieved for each baby within 24 hours following uploading of images in order to provide timely feedback to the examining ophthalmologist. [ Time Frame: 6 months ]
    Interval from uploading the images to the secure server to the time a grading report is submitted to the Clinical Center



Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature babies (N=500) with birth weights of <1251g who meet current ROP screening guidelines in 5 NICUs in US.
Criteria

Inclusion Criteria:

  1. Babies with birth weights of <1251g
  2. Babies having clinical examinations to screen for ROP

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257307


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Eye Institute (NEI)
Investigators
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Study Chair: Graham E Quinn, MD, MSCE Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02257307     History of Changes
Other Study ID Numbers: 14-010824
U10EY017014 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Keywords provided by Children's Hospital of Philadelphia:
ROP
retinopathy
Referral warranted retinopathy

Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases