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Completed

NCT Number: NCT01264276

Telemedicine Approaches to Evaluating Acute-phase ROP

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).

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

32 week–40 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Detection of Referral Warranted ROP

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Boston Children's Hospital
  • Duke University
  • Johns Hopkins University
  • National Eye Institute (NEI)
  • Nationwide Children's Hospital
  • The University of Texas at San Antonio
  • University of Calgary
  • University of Louisville
  • University of Minnesota
  • University of Oklahoma
  • University of Pennsylvania
  • University of Utah
  • Vanderbilt University

Registry information

Acronym: e-ROP

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 21, 2010
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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