Telemedicine Approaches to Evaluating Acute-phase ROP

Status:	Completed
Conditions:	Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	Any
Updated:	11/23/2013
Start Date:	July 2011
End Date:	June 2014
Contact:	Agnieshka Baumritter, MS
Email:	baumritter@email.chop.edu
Phone:	215 590 4956

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).

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).

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.

We found this trial at

sites

Children's Hospital - Boston

300 Longwood Avenue
Boston, Massachusetts 02115

617-355-6000