Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 90
Updated:3/6/2019
Start Date:October 2005
End Date:August 2020
Contact:Catherine Randall
Email:catherine.randall@nyumc.org
Phone:212 263 7563

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Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye

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.

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

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.

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.
We found this trial at
2
sites
Pittsburgh, Pennsylvania 15213
Phone: 412-383-8778
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Gadi Wollstein, MD
Phone: 212-263-7563
New York University School of Medicine NYU School of Medicine has a proud history that...
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