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

3 februari 2015 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Prematuritets retinopati

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Faktisk)

269

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

7 månader till 9 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
Detection of Referral Warranted ROP Tidsram: 6 weeks	6 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Hospital of Philadelphia

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2011

Primärt slutförande (Faktisk)

1 oktober 2013

Avslutad studie (Faktisk)

1 januari 2014

Studieregistreringsdatum

Först inskickad

20 december 2010

Först inskickad som uppfyllde QC-kriterierna