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Clinical trialNCT01264276CompletedObservational

Telemedicine Approaches to Evaluating Acute-phase ROP

SponsorChildren's Hospital of PhiladelphiaEnrollment269Retinopathy of Prematurity
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • University of Calgary

    Calgary, Alberta, Canada

United States
  • University of Louisville

    Louisville, Kentucky, United States

  • Johns Hopkins University

    Baltimore, Maryland, United States

  • Children'S Hospital Boston

    Boston, Massachusetts, United States

  • University of Minnesota

    Minneapolis, Minnesota, United States

  • Duke University

    Durham, North Carolina, United States

  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, United States

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Vanderbilt University

    Nashville, Tennessee, United States

  • University of Texas San Antonio

    San Antonio, Texas, United States

  • University of Utah

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2011
Primary completion
31 Oct 2013
Completion
31 Jan 2014
Last update posted
4 Feb 2015
Registered enrollment
269
Registry id
NCT01264276

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.