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Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye

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ClinicalTrials.gov Identifier: NCT00343473
Recruitment Status : Active, not recruiting
First Posted : June 23, 2006
Last Update Posted : February 1, 2021
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.

Condition or disease
Fuch's Dystrophy Corneal Disorders Prior Surgery

Detailed Description:
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the FDA. This study will also be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical Center New England Eye Center in Massachusetts

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Other
Time Perspective: Other
Official Title: Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye
Actual Study Start Date : October 2005
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye [ Time Frame: 2 years ]
    The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will range form 18 years to 90 years. Gender can be male or female. Will include 100 normals and 100 diseased patients that include diabetic retinopathy, macular degeneration, and glaucoma.
Criteria

Inclusion Criteria: Female Subjects who are pregnant or breastfeeding will be included (no risks to fetus).

Normals: Normal appearing cornea, no history of corneal trauma, surgery or disease, no historical or current contact lens wear. Thirty subjects from 6 different age groups (> 18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; > 60 yrs) will be recruited to determine the normal variations in anterior eye structure.

LASIK patients: to participate as a LASIK patient, the subject is previously normal but may have worn contact lenses, and is scheduled to undergo LASIK.

Contact lens wearers: to participate as a contact lens wearer the patient otherwise fulfills all criteria specified for normalcy, with the exception of contact lens wear.

Fuchs' dystrophy patients: Fuchs' Dystrophy is characterized by guttata and clinically significant corneal edema, with a corneal thickness of >700 microns, and/or reduced visual acuity in the morning which improves over the course of the day.

Diabetic patients: for diabetic patients are specified in the posterior segment imaging section.

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Exclusion Criteria:Subjects will be excluded from the study if their media are opaque, or if they are unwilling or unable to participate in the study.

If participants choose they may also participate in other imaging research protocols. No risk is associated if entering multiple imaging protocols, while being a participant in this research study.

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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): NCT00343473


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, Pennsylvania
University of Pittsburgh UPMC Eye Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
NYU Langone Health
National Eye Institute (NEI)
Investigators
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Principal Investigator: Chaim Wollstein, MD NYU Langone Health
Principal Investigator: Ian Conner, MD, PhD University of Pittsburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00343473    
Obsolete Identifiers: NCT00343746
Other Study ID Numbers: s17-00039
R01EY011289-15 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
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:
Fuch's dystrophy
corneal disorders
cornea
lasik
refractive surgery
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Diseases
Corneal Dystrophies, Hereditary
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn