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

3. februar 2015 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Prematuritets retinopati

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

269

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

7 måneder til 9 måneder (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Detection of Referral Warranted ROP Tidsramme: 6 weeks	6 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Children's Hospital of Philadelphia

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2011

Primær fullføring (Faktiske)

1. oktober 2013

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

20. desember 2010

Først innsendt som oppfylte QC-kriteriene