Telemedicine Approaches to Evaluating Acute-phase ROP

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).

Conditions

• Retinopathy of Prematurity

Sponsors & Collaborators

• Johns Hopkins University

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• The University of Texas at San Antonio

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• Children's Hospital of Philadelphia

  lead OTHER

Principal Investigators

• Graham E Quinn, MD, MSCE · Children's Hospital of Philadelphia

Eligibility

Min Age

32 Weeks

Max Age

40 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2013-10-31

Completion

2014-01-31

Countries

• United States
• Canada

Study Locations