Novel Diagnostics for Ocular Structure

• ClinicalTrials.gov Identifier: NCT00286637
• Recruitment Status: Recruiting
• First Posted: February 3, 2006
• Last Update Posted: August 24, 2020
• Sponsor: NYU Langone Health
• Collaborator: National Eye Institute (NEI)
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: February 2, 2006
• First Posted Date: February 3, 2006
• Last Update Posted Date: August 24, 2020
• Study Start Date: January 1995
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 2, 2014)

Novel Diagnostics for Ocular Structure [ Time Frame: 5 years ]

The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Novel Diagnostics for Ocular Structure
• Official Title: Optical Coherence Tomography Domain Reflectometry & Optical Coherence Tomography Measurements of Intraocular Structure
• Brief Summary: The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases

Detailed Description

Objective:

The purpose of this research is to evaluate a new technology, optical coherence tomography (OCT), to image diseases of the eye and to compare the measurements obtained using OCT with those of other imaging and visual field devices. OCT may be useful for the early diagnosis and monitoring of a variety of eye diseases such as age-related macular degeneration (ARMD), glaucoma, diabetic retinopathy, macular edema, and other pathologies.

Specific Aims:

There are three sub-studies: cross-sectional, longitudinal and reproducibility. The cross-sectional and longitudinal arms study the effectiveness of the OCT technology in terms of detecting and monitoring eye diseases. The reproducibility study is designed to test the measurement likeness of the OCT.

Background:

This is a continuation of an ongoing study from the New England Eye Center (NEEC), Tufts Medical Center, Boston, MA. This study started when our research group was located at NEEC and in collaboration with the Massachusetts Institute of Technology (MIT) where we conducted the first clinical studies with OCT. The first investigation using OCT was published in Science in 1991 and showed in vitro imaging of the human retina and atherosclerotic plaque. We developed an OCT prototype system for performing preliminary ophthalmic clinical studies and in 1993, began clinical OCT imaging studies.

The prototype ophthalmic OCT instrument acquired OCT images of the retina with an axial resolution of 10µm within an acquisition time of 2.5 sec. The OCT imaging system was integrated with a slit-lamp biomicroscope for in vivo tomography of the anterior and posterior eye. The beam is directed into the eye using computer controlled galvonometric scanners, which can scan arbitrary transverse patterns. The beam focus is coincident with the slit-lamp image plane to permit simultaneous scanning and visualization of the eye through the slit-lamp or via a CCD camera. For tomography of the anterior eye, the microscope is focused directly on the structure, while for retinal imaging, a lens relay images of the retina onto the slit-lamp image plane. A computer provides real-time display of the tomogram, image processing, and data management.

OCT technology was patented and subsequently transferred to industry (Zeiss Humphrey Systems, CA). Our prototype ophthalmic OCT system was developed into a clinical instrument and was introduced into the ophthalmic market in 1996. The commercial OCT technology has an axial resolution of 10 µm and can acquire a 100 transverse pixel retinal tomogram in 1 second. A third generation ophthalmic OCT imaging device, OCT3, was introduced three years ago. OCT imaging is now used as a standard diagnostic procedure as part of an ophthalmic examination for many retina and glaucoma patients at the University of Pittsburgh Medical Center (UPMC) Eye Center and New England Eye Center (NEEC). OCT imaging is in use in major research and clinical centers internationally. The OCT has been approved by the Food and Drug Administration for use in ophthalmology.

Significance:

OCT enables tissue pathology to be imaged in situ and in real time with a resolution approaching that of conventional histopathology but without the need for excising and processing specimens. OCT provides a quantitative method of directly measuring ocular structures with high precision and could provide an objective, early diagnosis for glaucoma, age related macular degeneration (ARMD), diabetic retinopathy, macular edema, and other pathologies. Extensive studies have been performed with OCT in cross-sectional as well as longitudinal setting. In this ongoing protocol, our objective is to continue these studies using the commercial ophthalmic OCT imaging instruments to develop methods for early detection and improve longitudinal assessment for the above mentioned ocular pathologies.

• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Recruiting subjects male or female, ages beginning at 18 with Macular dgegeneration, diabetic retinopathy, and/or glaucoma. Can also be a normal/healthy subject.

Condition

• Glaucoma
• Macular Disease

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Mumcuoglu T, Townsend KA, Wollstein G, Ishikawa H, Bilonick RA, Sung KR, Kagemann L, Schuman JS; Advanced Imaging in Glaucoma Study Group. Assessing the relationship between central corneal thickness and retinal nerve fiber layer thickness in healthy subjects. Am J Ophthalmol. 2008 Oct;146(4):561-6. doi: 10.1016/j.ajo.2008.05.038. Epub 2008 Jul 26.
• Gabriele ML, Ishikawa H, Wollstein G, Bilonick RA, Townsend KA, Kagemann L, Wojtkowski M, Srinivasan VJ, Fujimoto JG, Duker JS, Schuman JS. Optical coherence tomography scan circle location and mean retinal nerve fiber layer measurement variability. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2315-21. doi: 10.1167/iovs.07-0873.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 11, 2017): 2767
• Original Enrollment (submitted: February 2, 2006): 500
• Estimated Study Completion Date: January 2025
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Age older than or equal to 18 years old
2. Macular Degeneration, Diabetic Retinopathy, and/or glaucoma patients.
3. Normal control subjects

Exclusion Criteria:

1. Media opacity (lens, vitreous, cornea)
2. Strabismus, nystagmus, or a condition that would prevent fixation.
3. Inability to understand informed consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Stacy L Mach; 646-501-9883; Stacy.Mach@nyumc.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00286637
• Other Study ID Numbers: R01EY013178-06( U.S. NIH Grant/Contract ); R01EY011289-21 ( U.S. NIH Grant/Contract ); P30EY008098 ( U.S. NIH Grant/Contract ); 16-01302 ( Other Identifier: NYUMC IRB )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: NYU Langone Health
• Study Sponsor: NYU Langone Health
• Collaborators: National Eye Institute (NEI)

Investigators

• Study Chair: Joel S Schumann, MD; NYU Langone Health

• PRS Account: NYU Langone Health
• Verification Date: August 2020