Telemedicine Approaches to Evaluating Acute-phase ROP

Retinopathy of Prematurity Clinical Trial

— e-ROP  

Official title:

Telemedicine Approaches to Evaluating Acute-phase ROP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264276
• Other study ID #: 10-007554
• Secondary ID: U10EY017014-01A2
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: February 3, 2015
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 40 Weeks

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
United States	Johns Hopkins University	Baltimore	Maryland
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	University of Louisville	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas San Antonio	San Antonio	Texas

Sponsors (14)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Hospital Boston, 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 - Clinical and Translational Science Institute, University of Oklahoma, University of Pennsylvania, University of Utah, Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Referral Warranted ROP		6 weeks	Yes