Study Stopped
expired study
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project
2 other identifiers
observational
244
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2016
CompletedApril 13, 2017
April 1, 2017
9 months
October 2, 2014
April 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Interval from uploading the images to the secure server to the time a grading report is submitted to the Clinical Center
6 months
Interventions
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.
Eligibility Criteria
Premature babies (N=500) with birth weights of \<1251g who meet current ROP screening guidelines in 5 NICUs in US.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital of Philadelphialead
- National Eye Institute (NEI)collaborator
Study Sites (5)
Johns Hopkins University
Baltimore, Maryland, 21205, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Utah
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Graham E Quinn, MD, MSCE
Children's Hospital of Philadelphia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 6, 2014
Study Start
July 1, 2014
Primary Completion
April 1, 2015
Study Completion
March 16, 2016
Last Updated
April 13, 2017
Record last verified: 2017-04