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Novel Diagnostics for Ocular Structure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286637
Recruitment Status : Recruiting
First Posted : February 3, 2006
Last Update Posted : August 24, 2020
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
NYU Langone Health

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

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Study Type : Observational
Estimated 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 : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine





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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Contacts
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Contact: Stacy L Mach 646-501-9883 Stacy.Mach@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Stacy L Mach    646-501-9883    Stacy.Mach@nyumc.org   
Principal Investigator: Joel S Schuman, MD         
Sub-Investigator: Gadi Wollstein, MD         
Sub-Investigator: Hiroshi Ishikawa, MD         
Sub-Investigator: Ian Conner, MD, PhD         
Sponsors and Collaborators
NYU Langone Health
National Eye Institute (NEI)
Investigators
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Study Chair: Joel S Schumann, MD NYU Langone Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00286637    
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: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
OCT
CSLO
SLP
Perimetry
electrophysiology
glaucoma
macular degeneration
retinopathy
diabetes
macular hole
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases