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

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ClinicalTrials.gov Identifier: NCT01264276
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : February 4, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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).

Condition or disease
Retinopathy of Prematurity

Detailed Description:

Eligibility Criteria:

• Babies with birth weights of <1251 grams(g) at selected large clinical centers in the US and Canada.


• 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.


• 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).

Study Design

Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telemedicine Approaches to Evaluating Acute-phase ROP
Study Start Date : July 2011
Primary Completion Date : October 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Detection of Referral Warranted ROP [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Babies with birth weighs of <1251g at selected large clinical centers in the US

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264276

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
Children's Hospital of Philadelphia
Johns Hopkins University
Boston Children’s Hospital
Nationwide Children's Hospital
Duke University
University of Louisville
University of Minnesota - Clinical and Translational Science Institute
University of Oklahoma
The University of Texas at San Antonio
University of Utah
University of Pennsylvania
Vanderbilt University
University of Calgary
National Eye Institute (NEI)
Principal Investigator: Graham E Quinn, MD, MSCE Children's Hospital of Philadelphia
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01264276     History of Changes
Other Study ID Numbers: 10-007554
U10EY017014-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Children's Hospital of Philadelphia:
Retinopathy of Prematurity

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases