Telemedicine Approaches to Evaluating Acute-phase ROP
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Observational

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).
    

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).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Babies with birth weighs of <1251g at selected large clinical centers in the US
      
Keywords: ROP; Retinopathy of Prematurity; Telemedicine