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Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye

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ClinicalTrials.gov Identifier: NCT00343473
Recruitment Status : Recruiting
First Posted : June 23, 2006
Last Update Posted : February 8, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
New York University School of Medicine

June 19, 2006
June 23, 2006
February 8, 2018
October 2005
January 2019   (Final data collection date for primary outcome measure)
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
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Complete list of historical versions of study NCT00343473 on ClinicalTrials.gov Archive Site
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Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye
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
Observational
Observational Model: Other
Time Perspective: Other
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Non-Probability Sample
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.
  • Fuch's Dystrophy
  • Corneal Disorders
  • Prior Surgery
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Christopoulos V, Kagemann L, Wollstein G, Ishikawa H, Gabriele ML, Wojtkowski M, Srinivasan V, Fujimoto JG, Duker JS, Dhaliwal DK, Schuman JS. In vivo corneal high-speed, ultra high-resolution optical coherence tomography. Arch Ophthalmol. 2007 Aug;125(8):1027-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
201
200
January 2020
January 2019   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Older Adult)
Yes
Contact: Catherine Randall 212 263 7563 catherine.randall@nyumc.org
United States
 
 
NCT00343473
0309020
R01EY011289-15 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
New York University School of Medicine
New York University School of Medicine
National Eye Institute (NEI)
Principal Investigator: Gadi Wollstein, MD New York University School of Medicine
Principal Investigator: Ian Conner, MD, PhD University of Pittsburgh
New York University School of Medicine
February 2018