Retinal Diseases Clinical Trial
— OCTOfficial title:
Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
Verified date | July 2017 |
Source | Los Angeles Biomedical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 38 Weeks to 42 Weeks |
Eligibility |
Inclusion Criteria: - Healthy term, gestational age of 38-42 weeks inclusive. - Able to be transported to the Eye Clinic. - No longer monitored. On no intravenous or other lines. Exclusion Criteria: - History of hyperglycemia in the infant (a blood sugar greater than 100mg%, per Laboratory Policy on Critical Values for infants less than 20 days old). - Feeding intolerance. - Green-tinged aspirates/emesis. - Abdominal distention. - History of genetic consult indicating any abnormality. - Any known ocular disorder. |
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles Biomedical Research Institute atHarbor-UCLA Medical Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Los Angeles Biomedical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specific eye measurements by SD-OCT, including retinal nerve fiber layer thickness per quadrant, foveal depth, optic cup area and depth, optic nerve/foveal distance and depth of various layers within the retina to determine neonatal baseline values. | A spreadsheet of the data collected from the study population will be created. The data will be derived from analysis of the images captured by the instrument. Software within the computer of the instrument will provide data from each image including measurements of retinal nerve fiber layer thickness in each quadrant, depth of the fovea, depth and area of the optic cup, distance from the optic nerve to the fovea, and depth of the various layers within the retina. These parameters will be calculated to establish normal values for the first time. | 24 months |
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