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Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates (OCT)

Primary Purpose

Retinal Diseases, Optic Nerve Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).
OCT imaging.
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Retinal Diseases focused on measuring retina, optic nerve, fovea, Eyes, Neonates

Eligibility Criteria

38 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Los Angeles Biomedical Research Institute atHarbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OCT imaging in neonates

Arm Description

OCT imaging of all neonates, 38-42 weeks, enrolled in this study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2011
Last Updated
July 10, 2017
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01404247
Brief Title
Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
Acronym
OCT
Official Title
Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Diseases, Optic Nerve Diseases
Keywords
retina, optic nerve, fovea, Eyes, Neonates

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCT imaging in neonates
Arm Type
Experimental
Arm Description
OCT imaging of all neonates, 38-42 weeks, enrolled in this study
Intervention Type
Other
Intervention Name(s)
Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
OCT imaging.
Other Intervention Name(s)
OCT imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherwin J Isenberg, M.D.
Organizational Affiliation
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Biomedical Research Institute atHarbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

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Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates

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