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NCT01404247 · ClinicalTrials.gov registry record · Phase 1

Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates

A Phase 1 study of Retinal Diseases and Optic Nerve Diseases, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT01404247: Completed Phase 1 study of Retinal Diseases and Optic Nerve Diseases, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

NCT01404247 is a Phase 1 study of Retinal Diseases and Optic Nerve Diseases that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 20 participants, below the 394-participant average among 8 other Retinal Diseases trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01404247, a Phase 1 study of Retinal Diseases and Optic Nerve Diseases, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study 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 th

Primary Outcome

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 calcul

Interventions

  • OTHER Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).
  • PROCEDURE OCT imaging.

Study Locations (1)

California

  • Los Angeles Biomedical Research Institute atHarbor-UCLA Medical Center - Torrance

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-01
Est. Completion 2015-12
Phase Phase 1

What the finished NCT01404247 record still lists

NCT01404247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 394-participant average among 8 other Retinal Diseases trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Retinal Diseases appearing as the primary indexed condition, and to 2 interventions - of which Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct). is the first listed.

NCT01404247 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01404247 about?

NCT01404247 is a clinical study titled "Spectral Domain Optical Coherence Tomography Imaging of the Eyes of Neonates". 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...

What is the current status of trial NCT01404247?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-01. Estimated completion is 2015-12.

What conditions does trial NCT01404247 study?

This clinical trial studies the following conditions: Retinal Diseases, Optic Nerve Diseases.

What interventions are being tested in trial NCT01404247?

The interventions under investigation include: Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct). (OTHER), OCT imaging. (PROCEDURE).

Who is sponsoring clinical trial NCT01404247?

This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01404247 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Retinal Diseases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01404247's enrollment target sits among peer trials

20 4th of 8 higher than 5 of 8 other Retinal Diseases trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Retinal Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01404247, the US trial registry maintained by the National Library of Medicine. NCT01404247 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.