NCT02257307

Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Ancillary Study - Implementation Project

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 32 Weeks – 40 Weeks
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Retinopathy of Prematurity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-04-01
• Completion: 2016-03-16
• First posted: 2014-10-06
• Last updated: 2017-04-13

Locations

5 sites across 1 country: United States