Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286637
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2006-02-02
Brief Title:
Novel Glaucoma Diagnostics
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Novel Diagnostics for Ocular Structure
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 four sub-studies cross-sectional longitudinal reproducibility and an Alzheimers Disease AD sub-study 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 The AD sub-study will use high resolution ocular imaging technologies to determine ocular biomarkers for sensitive detection of AD
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 25 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
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 four sub-studies cross-sectional longitudinal reproducibility and an Alzheimers Disease AD sub-study 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 The AD sub-study will use high resolution ocular imaging technologies to determine ocular biomarkers for sensitive detection of AD
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 25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01EY011289-21 | NIH | None | None |
| P30EY008098 | NIH | None | httpsreporternihgovquickSearchP30EY008098 |