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Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

NCT02257307 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 244

Last updated 2017-04-13

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Graham E Quinn, MD, MSCE · Children's Hospital of Philadelphia

Eligibility

Min Age
32 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-04-30
Completion
2016-03-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02257307 on ClinicalTrials.gov