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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh UPMC Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• 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.

Description

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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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Novel Diagnostics With Optical Coherence Tomography: Imaging 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	2 years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Chaim Wollstein, MD, NYU Langone Health; Principal Investigator: Ian Conner, MD, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2005
• Primary Completion (Actual): September 12, 2019
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: June 19, 2006
• First Submitted That Met QC Criteria: June 22, 2006
• First Posted (Estimated): June 23, 2006

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cornea; refractive surgery; lasik; Fuch's dystrophy; corneal disorders
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Dystrophies, Hereditary; Corneal Diseases; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: s17-00039; R01EY011289-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No