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Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP)

3 februari 2015 bijgewerkt door: Children's Hospital of Philadelphia

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:

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);
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);
Determine whether imaging evaluation can be achieved for each baby (feasibility);
Examine ocular and systemic complications associated with digital imaging and compared with those associated with diagnostic examinations performed by an ophthalmologist (safety);
Compare the costs and benefits of adopting a telemedicine retinal imaging system compared to the current cost of indirect ophthalmoscopic examinations (cost-effectiveness).

Studie Overzicht

Toestand

Voltooid

Conditie

Retinopathie van prematuren

Gedetailleerde beschrijving

Eligibility Criteria:

• Babies with birth weights of <1251 grams(g) at selected large clinical centers in the US and Canada.

Procedures:

• Participants will undergo both digital retinal imaging and clinically indicated indirect ophthalmoscopic examinations on the same day. Wide-field digital images (WF-DI) of both eyes will be captured by non-physician Certified ROP Imagers (CRIs) using standardized imaging protocols. The RetCam Shuttle® (Clarity Medical Systems, Pleasanton, CA), a corneal-contact camera that captures wide field (130 degree field of view) retinal images, will be used.

Masking:

• Study-certified Ophthalmologist and Study-certified Imager at the clinical sites will be masked to each other's findings. The Study Clinical Coordinator (SCC) will remain unmasked. SCC will monitor the clinical noteworthy events and report all adverse events to the site Institutional Review Board (IRB), the Project Director at the Office of Study Chair, and to the Data Coordinating Center (DCC). DCC will prepare closed-session Data Monitoring and Oversight Committee (DMOC) reports. The PI at each site will monitor adverse events.

Outcome Measures:

• The primary outcome measure is detection of referral warranted ROP (RW-ROP) on digital images. Retinal images will be graded by Trained Readers using a standardized protocol to identify eyes with RW-ROP. Results of the gradings will be compared to the diagnostic examinations being performed on each child at the same session when images taken. For comparison, images will also be graded by ROP experts (Expert Readers).

Studietype

Observationeel

Inschrijving (Werkelijk)

269

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 1N4
    - University Of Calgary
Verenigde Staten
- Kentucky
  - Louisville, Kentucky, Verenigde Staten, 40202
    - University of Louisville
- Maryland
  - Baltimore, Maryland, Verenigde Staten, 21287
    - Johns Hopkins University
- Massachusetts
  - Boston, Massachusetts, Verenigde Staten, 02115
    - Children's Hospital Boston
- Minnesota
  - Minneapolis, Minnesota, Verenigde Staten, 55455
    - University of Minnesota
- North Carolina
  - Durham, North Carolina, Verenigde Staten, 27710
    - Duke University
- Ohio
  - Columbus, Ohio, Verenigde Staten, 43205
    - Nationwide Children's Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Verenigde Staten, 73104
    - University of Oklahoma
- Pennsylvania
  - Philadelphia, Pennsylvania, Verenigde Staten, 19104
    - Children's Hospital of Philadelphia
- Tennessee
  - Nashville, Tennessee, Verenigde Staten, 37232
    - Vanderbilt University
- Texas
  - San Antonio, Texas, Verenigde Staten, 78229
    - University of Texas San Antonio
- Utah
  - Salt Lake City, Utah, Verenigde Staten, 84132
    - University of Utah

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 maanden tot 9 maanden (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
Detection of Referral Warranted ROP Tijdsspanne: 6 weeks	6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Children's Hospital of Philadelphia

Medewerkers

Johns Hopkins University

University of Pennsylvania

National Eye Institute (NEI)

Boston Children's Hospital

University of Oklahoma

Duke University

Vanderbilt University

University of Minnesota

Nationwide Children's Hospital

University of Calgary

University of Utah

University of Louisville

The University of Texas at San Antonio

Onderzoekers

Hoofdonderzoeker: Graham E Quinn, MD, MSCE, Children's Hospital of Philadelphia

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2011

Primaire voltooiing (Werkelijk)

1 oktober 2013

Studie voltooiing (Werkelijk)

1 januari 2014

Studieregistratiedata

Eerst ingediend

20 december 2010

Eerst ingediend dat voldeed aan de QC-criteria