Telemedicine Approaches to Evaluating Acute-phase ROP

Completed

Conditions studied: Retinopathy of Prematurity

In brief

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).

Key facts

Study ID

NCT01264276

Run by

Children's Hospital of Philadelphia

People needed

269

Starts

2011-07-01

Expected to finish

2014-01-01

Last updated by the study team

2015-02-04

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Calgary — Calgary, Alberta, Canada

Full record on ClinicalTrials.gov

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