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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Johns Hopkins University
Children's Hospital Boston
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
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01264276
First received: December 20, 2010
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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
Retinopathy of Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telemedicine Approaches to Evaluating Acute-phase ROP

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Detection of Referral Warranted ROP [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: July 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   32 Weeks to 40 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264276

Locations
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
Children's Hospital Boston
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
Investigators
Principal Investigator: Graham E Quinn, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional 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
Study First Received: December 20, 2010
Last Updated: November 21, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on October 16, 2014