Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-03-16

Brief Summary

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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.

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Detailed Description

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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

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Retinopathy of Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

32 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No