Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

Retinopathy of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02257307
• Other study ID #: 14-010824
• Secondary ID: U10EY017014
• Status: Terminated
• Phase: N/A
• First received: October 2, 2014
• Last updated: April 11, 2017
• Start date: July 2014
• Est. completion date: March 16, 2016

Study information

• Verified date: April 2017
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 244
• Est. completion date: March 16, 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 40 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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