ROPCORIMAP - Retinal Oximetry in Retinopathy of Prematurity with the Compact Retinal Mapper Camera

Retinopathy of prematurity (ROP) is a potential blinding disease of premature
born infants. Oxygen plays a pivotal role in the pathophysiology of ROP. With
the introduction of retinal oximetry for infants, this pilot study aims to
increase the insight into the oxygen metabolism of the developing retina of
premature born infants. Retinal oximetry utilizes the difference in light
absorption of hemoglobin bound and unbound to an oxygen molecule for
measurement of relative oxygen saturation within the retinal vessels. With the
introduction of the newly developed CORIMAP retinal oximeter, dual wavelength
retinal oximetry has become available for use in preterm infants to monitor the
oxygen saturation in the retinal vessels.

The objective of this pilot study is to measure the ODR of the retinal vessels
in infants at risk of developing ROP. The secondary objective is to measure the
vessel diameter of the retinal vessels in infants at risk of developing ROP

This prospective cohort pilot study will be performed at the Neonatal Intensive
Care Unit of the department of Neonatology of the LUMC. This imaging study will
be incorporated in the current ROP screening program according to the Dutch ROP
guideline to minimize the burden for the infants. After approval and the
initial start of this study the duration will be until 30-50 infants are
included.

The benefit of this study will be an increase of insight into the retinal
oxygen metabolism of infants with the risk of ROP with non-invasive retinal
oximetry imaging. The study procedure will be combined with the regular Dutch
ROP screening protocol with the RetCam II, which includes the necessity of
mydriasis and the use of eyelid specula.

The nature and extent of the burden of this study will be minimal, although
this investigation will take place in very fragile preterm infants. The study
is designed in a fashion to ensure minimal burden to this study population. The
burden will consist of an extension of examination time by 10 min ( and the
enquiring of three extra images per eye with minimal light exposure with the
non-contact CORIMAP Camera. The regular ROP screening consultation with the
invasive RetCam examination (corneal contact, continuous illumination) will
take up to 60 minutes, including the preparation of the infants. Therefore, the
potential benefits in management, possible prevention and treatment of retinal
oximetry in this fragile patient population outweigh the minimal burden of this
investigation.