Brief Summary

The primary objective of this multi-center clinical study is to evaluate the validity, reliability, feasibility, safety and relative cost-effectiveness of a retinopathy of prematurity (ROP) telemedicine evaluation system to detect eyes of at-risk babies who meet referral warranted ROP (RW-ROP) criteria and therefore need a diagnostic evaluation by an ophthalmologist experienced in ROP. We shall:

1.Calculate the accuracy, using sensitivity and specificity, of the system to provide remote evaluations when compared with the findings of a "gold standard" indirect ophthalmoscopic examination performed by a Study-certified ophthalmologist, rigorously trained in ROP diagnostic examinations (validity);
2.Determine intra-reader and inter-reader agreement for deciding whether digital images indicate that the eyes of a baby are in need of diagnostic indirect ophthalmoscopy by an ophthalmologist experienced in ROP (reliability);
3.Determine whether imaging evaluation can be achieved for each baby (feasibility);
4.Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety);
5.Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

269

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach

2 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

December 20, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed

6 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed

Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

December 20, 2010

Last Update Submit

February 3, 2015

Conditions

Retinopathy of Prematurity

Keywords

ROPRetinopathy of PrematurityTelemedicine

Outcome Measures

Primary Outcomes (1)

Detection of Referral Warranted ROP
6 weeks

Eligibility Criteria

Age32 Weeks - 40 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodProbability Sample

Study Population

Babies with birth weighs of \<1251g at selected large clinical centers in the US

You may qualify if:

Babies with birth weighs of \<1251g at selected large clinical centers in the US and Canada.
Admitted to a participating Neonatal Intensive Care Units (NICU) and expected to survive to 28 days.
Likely to remain in participating NICU for serial ROP exams.
Transferred to participating NICU for treatment of ROP (regardless of PMA).
Parents or guardians have provided informed consent for participation in the study.

You may not qualify if:

Failure to obtain informed consent.
Known ocular anomalies that prevent imaging of the retina.
Life threatening anomalies (i.e. heart, neurological, etc).
Admission to participating NICU with ROP that is already regressing or treated.

Contact the study team to confirm eligibility.

Study Sites (12)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas San Antonio

San Antonio, Texas, 78229, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (8)

Wade KC, Ying GS, Baumritter A, Gong A, Kemper AR, Quinn GE; e-ROP Cooperative Group. Factors in Premature Infants Associated With Low Risk of Developing Retinopathy of Prematurity. JAMA Ophthalmol. 2019 Feb 1;137(2):160-166. doi: 10.1001/jamaophthalmol.2018.5520.
PMID: 30452500DERIVED
Morrison D, Bothun ED, Ying GS, Daniel E, Baumritter A, Quinn G; e-ROP Cooperative Group. Impact of number and quality of retinal images in a telemedicine screening program for ROP: results from the e-ROP study. J AAPOS. 2016 Dec;20(6):481-485. doi: 10.1016/j.jaapos.2016.08.004. Epub 2016 Oct 1.
PMID: 27702612DERIVED
Quinn GE, Ying GS, Repka MX, Siatkowski RM, Hoffman R, Mills MD, Morrison D, Daniel E, Baumritter A, Hildebrand PL, Schron EB, Ells AL, Wade K, Kemper AR. Timely implementation of a retinopathy of prematurity telemedicine system. J AAPOS. 2016 Oct;20(5):425-430.e1. doi: 10.1016/j.jaapos.2016.06.007. Epub 2016 Sep 17.
PMID: 27651231DERIVED
Kemper AR, Prosser LA, Wade KC, Repka MX, Ying GS, Baumritter A, Quinn GE; e-ROP Study Cooperative Group. A Comparison of Strategies for Retinopathy of Prematurity Detection. Pediatrics. 2016 Jan;137(1):e20152256. doi: 10.1542/peds.2015-2256. Epub 2015 Dec 15.
PMID: 26672022DERIVED
Wade KC, Pistilli M, Baumritter A, Karp K, Gong A, Kemper AR, Ying GS, Quinn G; e-Retinopathy of Prematurity Study Cooperative Group. Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants. J Pediatr. 2015 Nov;167(5):994-1000.e2. doi: 10.1016/j.jpeds.2015.07.050. Epub 2015 Aug 20.
PMID: 26299381DERIVED
Kemper AR, Wade KC, Hornik CP, Ying GS, Baumritter A, Quinn GE; Telemedicine Approaches to Evaluating Acute-phase Retinopathy of Prematurity (e-ROP) Study Cooperative Group. Retinopathy of prematurity risk prediction for infants with birth weight less than 1251 grams. J Pediatr. 2015 Feb;166(2):257-61.e2. doi: 10.1016/j.jpeds.2014.09.069. Epub 2014 Nov 12.
PMID: 25449219DERIVED
Quinn GE, Ying GS, Daniel E, Hildebrand PL, Ells A, Baumritter A, Kemper AR, Schron EB, Wade K; e-ROP Cooperative Group. Validity of a telemedicine system for the evaluation of acute-phase retinopathy of prematurity. JAMA Ophthalmol. 2014 Oct;132(10):1178-84. doi: 10.1001/jamaophthalmol.2014.1604.
PMID: 24970095DERIVED
Graham E Quinn; e-ROP Cooperative Group. Telemedicine approaches to evaluating acute-phase retinopathy of prematurity: study design. Ophthalmic Epidemiol. 2014 Aug;21(4):256-67. doi: 10.3109/09286586.2014.926940. Epub 2014 Jun 23.
PMID: 24955738DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Graham E Quinn, MD, MSCE
Children's Hospital of Philadelphia
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 21, 2010

Study Start

July 1, 2011

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

US(11)CA(1)

Telemedicine Approaches to Evaluating Acute-phase ROP

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations