Figure 140 Clarity Method: Five Images - Clarity RetCam3 User Manual

The set of images below represent the method taught by Clarity of taking five (5) images;
Chiang's approach plus two (2) more images, superior and inferior. As can be seen, there
is also overlap in all images.

Figure 140 Clarity Method: Five Images

Images were interpreted by three expert retinal specialist graders who provided a
diagnosis (No ROP, Mild ROP, Type 2 Pre-Threshold ROP, Treatment requiring ROP, or
unknown) and an evaluation of image quality. The diagnostic definitions of Type 2
Pre-Threshold ROP and Treatment requiring ROP are found below.
Mild ROP was defined as ROP less than Type 2 disease. A diagnosis of Unknown meant
the grader was uncomfortable making a diagnosis from the data provided. Findings were
compared with a reference standard of binocular indirect ophthalmoscopy (BIO) by
experienced pediatric ophthalmologists.
The target conditions (referral warranted disease – the presence of Type 2 pre-threshold,
or worse, ROP) in this study that supports the use of RetCam as an ROP screening tool
are:
• Type 2 Pre-threshold ROP (Zone 1, Stage 1 or 2, without Plus disease, or Zone 2,
• Treatment requiring ROP (Zone 1, any stage, with Plus disease; Zone 1, stage 3
RetCam 3 and RetCam Shuttle User Manual
OD Nasal View
Stage 3, without Plus disease), or
without Plus disease; or Zone 2, stage 2 or 3 with Plus disease), or
Screening for Retinopathy of Prematurity (ROP)
OD Superior View
OD Posterior Pole View
OD Inferior View
145
OD Temporal View
PN 18-000393 Rev. A