Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
Condition: Retinal Diseases; Optic Nerve Diseases
MeSH terms: Nervous System Diseases; Optic Nerve Diseases; Retinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Brief Summary

      The purpose of this study is to better characterize the retina and optic nerve in newborns
      using spectral domain optical coherence tomography (s-oct). This new technology provides a
      very detailed cross-section picture of the cellular layers in the retina and a 3-dimensional
      picture of the optic nerve head and the fovea (the center of the retina that provides the
      most accurate vision). These images have been used by doctors for more than 5 years to help
      diagnose and treat adults with eye diseases, such as macular degeneration, diabetic
      retinopathy, retinal detachments, and melanoma. But, it has never been studied in newborns.
      In newborns, it would potentially help in the diagnoses of glaucoma, optic nerve hypoplasia,
      foveal hypoplasia, and colobomata among many other disorders. Prior to diagnosing disorders,
      it is necessary to establish normal values. It is the purpose of this investigation to study
      the retina and optic nerves in neonates to establish normal values.

      After a parent of a normal newborn provides a written consent, the baby will be taken to the
      Eye Clinic where the instrument is located. The baby will be swaddled in one or more blankets
      as needed. The infants will be held in front of the instrument by a nurse. The technician
      will move the lens of the instrument to about 2 to 4 inches from the baby's eye. The mild
      light from the instrument will then enter the eye for a few seconds to obtain the desired
      image. The image can be captured through an immobile eye within 5 seconds. If the baby is
      fussy, he or she may be given a few drops of a sugar (sucrose) solution on a pacifier for
      calming. Although the images can usually be secured through a normal pupil, if the pupil is
      found to be too small, two drops of Cyclomydril will be placed on the eye for dilation. This
      is the eye drop used everyday in the Eye Clinic and nursery to dilate the pupils of babies.
      The dilation will last for about 6 to 10 hours. After the test, the baby will return to the
      nursery or be discharged home as intended by the Neonatology Division.

      There is minimal risk associated with this investigation. The instrument is non-invasive and
      does not touch the eye. The babies will be swaddled and held by a nurse to prevent any
      contact with the machine. The eye drop to be used if needed for dilation has been used on
      babies at Harbor for about 30 years. It has been found to very safe. The fact that we will
      study only term (not premature babies) and will apply only two drops if needed should
      minimize any risk from the eye drop.

      An ethical issue to consider is that while the study will provide important information that
      will undoubtedly help babies in the future, it will probably not benefit the baby being
      studied. However, if the baby has an undetected retinal or optic nerve problem, the study may
      reveal it.
    


Intervention name(s): Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).; OCT imaging.
Intervention type(s): Other; Procedure
Intervention description(s): The OCT technician will attempt to image the eyes of neonates. The neonate may be given Cyclomydril ophthalmic solution, if needed for dilation. Cyclomydril dosing for this study is 1 drop every 5 minutes times 2.; All newborns meeting eligibility requirements will undergo spectral domain optical coherence tomography imaging in order to better characterize the retina and optic nerve in newborns
Other intervention name(s): OCT imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: retina; optic nerve; fovea; Eyes; Neonates