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

3. februar 2015 opdateret af: 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:

  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).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

269

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 måneder til 9 måneder (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Children's Hospital of Philadelphia

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Graham E Quinn, MD, MSCE, Children's Hospital of Philadelphia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2011

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

20. december 2010

Først indsendt, der opfyldte QC-kriterier

20. december 2010

Først opslået (Skøn)

21. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10-007554
  • U10EY017014-01A2 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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