Telemedicine Approaches to Evaluating Acute-Phase ROP eRO... | NCT02257307

Studies
Telemedicine Approaches to Evaluating Acute-Phase ROP eROP Implementation Project

NCT02257307

Sponsor

Children's Hospital of Philadelphia

Status

Terminated

Last Update Posted

Apr 13, 2017Actual

Enrollment

244Actual

Phase

Not provided

Conditions

Retinopathy of Prematurity

Interventions

RetCam retinal imaging used for routine care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U10EY017014	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

expired study

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Mar 16, 2016Actual

First Submitted Date

Oct 2, 2014

First Submission Date that Met QC Criteria

Oct 2, 2014

First Posted Date

Oct 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2017

Last Update Posted Date

Apr 13, 2017Actual

Name	Class
National Eye Institute (NEI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

244Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RetCam retinal imaging used for routine care	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Babies with birth weights of <1251g
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

32 Weeks

Maximum Age

40 Weeks

Standard Ages

Child

Study Population

Premature babies (N=500) with birth weights of <1251g who meet current ROP screening guidelines in 5 NICUs in US.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Graham E Quinn, MD, MSCE	Children's Hospital of Philadelphia	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21205	United States
University of Oklahoma

Condition Browse Module

MeSH Terms

ID	Term
D012178	Retinopathy of Prematurity
D012164	Retinal Diseases

Ancestor Terms

ID	Term
D005128	Eye Diseases
D007235	Infant, Premature, Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided