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Novel Diagnostics for Ocular Structure

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ClinicalTrials.gov Identifier: NCT00286637
Recruitment Status : Active, not recruiting
First Posted : February 3, 2006
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases

Condition or disease
Glaucoma Macular Disease

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2767 participants
Observational Model: Other
Time Perspective: Other
Official Title: Optical Coherence Tomography Domain Reflectometry & Optical Coherence Tomography Measurements of Intraocular Structure
Study Start Date : January 1995
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Novel Diagnostics for Ocular Structure [ Time Frame: 5 years ]
    The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Recruiting subjects male or female, ages beginning at 18 with Macular dgegeneration, diabetic retinopathy, and/or glaucoma. Can also be a normal/healthy subject.
Criteria

Inclusion Criteria:

  1. Age older than or equal to 18 years old
  2. Macular Degeneration, Diabetic Retinopathy, and/or glaucoma patients.
  3. Normal control subjects

Exclusion Criteria:

  1. Media opacity (lens, vitreous, cornea)
  2. Strabismus, nystagmus, or a condition that would prevent fixation.
  3. Inability to understand informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286637


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Eye Institute (NEI)
Investigators
Study Chair: Joel S Schumann, MD New York University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00286637     History of Changes
Other Study ID Numbers: R01EY013178-06 ( U.S. NIH Grant/Contract )
R01EY011289-21 ( U.S. NIH Grant/Contract )
P30EY008098 ( U.S. NIH Grant/Contract )
16-01302 ( Other Identifier: NYUMC IRB )
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
OCT
CSLO
SLP
Perimetry
electrophysiology
glaucoma
macular degeneration
retinopathy
diabetes
macular hole

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases