Retinal DiseasesPhase 1OCTNCT01404247
Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
A Phase 1 study testing Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct). and OCT imaging. in people with Retinal Diseases and Optic Nerve Diseases, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 38 to 42 weeks
- Conditions the study is for
- Retinal Diseases, Optic Nerve Diseases
- What is being tested?
- Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct). and OCT imaging.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Research Institute atHarbor-UCLA Medical Center
Torrance, California, 90502
About this study
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.
Read more
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.
- Conditions
- Retinal Diseases, Optic Nerve Diseases
- Being tested
- Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct)., OCT imaging.
- Keywords
- retina, optic nerve, fovea, Eyes, Neonates
- Medical subject headings
- Retinal Diseases, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).Other
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.
OCT imaging.Procedure or surgery
Also called OCT imaging
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
| Study group | Role | What they receive |
|---|---|---|
| OCT imaging in neonates | Experimental | OCT imaging of all neonates, 38-42 weeks, enrolled in this study Receives: Other: Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).; Procedure: OCT imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwin Isenberg, University of California, Los Angeles
- Investigators
- Sherwin J Isenberg, M.D., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404247
- Sponsor's protocol ID
- 14069-01
- Acronym
- OCT
- Status last verified
- Jul 2017
- First submitted
- 10 May 2011
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates
- ClinicalTrials.gov ID
- NCT01404247
- Acronym / sponsor ID
- OCT / 14069-01
- Conditions
- Retinal Diseases, Optic Nerve Diseases
- Keywords
- retina, optic nerve, fovea, Eyes, Neonates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT imaging in neonates | Experimental | Other: Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct)., Procedure: OCT imaging.OCT imaging of all neonates, 38-42 weeks, enrolled in this study |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).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. | Other | OCT imaging in neonates |
| OCT imaging.Also: OCT imagingAll newborns meeting eligibility requirements will undergo spectral domain optical coherence tomography imaging in order to better characterize the retina and optic nerve in newborns | Procedure or surgery | OCT imaging in neonates |
Primary outcome
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.
Time frame: 24 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherwin J Isenberg, M.D. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct). and OCT imaging. in people with Retinal Diseases and Optic Nerve Diseases, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.