Clinical trial NCT00343473: Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye
Official title: Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fuch's Dystrophy
Corneal Disorders
Prior Surgery
Keywords: Fuch's dystrophy
corneal disorders
cornea
lasik
refractive surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2006-06-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

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

Eligibility 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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Primary outcomes:
measure: Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh UPMC Eye Center
state: Pennsylvania
Study officials:
affiliation: NYU Langone Health
name: Chaim Wollstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ian Conner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/archopht.125.8.1027.