GlaucomaNCT00286637
Novel Glaucoma Diagnostics
An observational study of Glaucoma and Macular Disease, run by Wills Eye at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Macular Disease
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2000to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study aims to enroll healthy volunteers and subjects with glaucoma, age related macular degeneration (AMD), diabetic retinopathy (DR), and central serous chorioretinopathy (CSCR). Participants with AD and MCI will be recruited as part of a sub-study.
Who may be able to join
- Ability to provide informed consent and to understand the study procedures
- Healthy volunteers
- Age related macular degeneration (AMD), diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects
- (AD Sub-Study ONLY): Subjects diagnosed with AD or MCI.
Who cannot join
- Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
- Strabismus, nystagmus, or any condition that prevents fixation.
- Presence of any media opacities that hinders clinical view of the fundus, and any intraocular non-glaucomatous abnormality
- History of ocular trauma or intraocular surgery other than uncomplicated glaucoma interventions or cataract extraction at least 3 months previous to participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Taylor Harwood, 215-928-3197, tharwood@willseye.org
Ronald Zambrano, 215-928-3197, rzambrano@willseye.org
About this study
Official title: Novel Diagnostics for Ocular Structure
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
Read the 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 Alzheimer's 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 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.
- Conditions
- Glaucoma, Macular Disease
- Keywords
- OCT, CSLO, SLP, Perimetry, electrophysiology, glaucoma, macular degeneration, retinopathy, diabetes, macular hole
- Medical subject headings
- Glaucoma, Macular Degeneration, Retinal Diseases, Diabetes Mellitus, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional Study | Subjects will undergo a comprehensive ocular examination at every visit. Frequency of the visits is dictated by the treating physician, disregarding participation in the study. In glaucoma clinic patients are typically scheduled for visits every six months, and the frequency of visits varies according to clinical severity in the retina clinic. No additional research visits are required beyond the clinically dictated schedule. | |
| Longitudinal Study | Subjects will undergo a comprehensive ocular examination at every visit. Frequency of the visits is dictated by the treating physician, disregarding participation in the study. In glaucoma clinic patients are typically scheduled for visits every six months, and the frequency of visits varies according to clinical severity in the retina clinic. No additional research visits are required beyond the clinically dictated schedule. | |
| Reproducibility Study | Subjects willing to participate in the reproducibility arm of the project will undergo the same comprehensive ocular examination as in the longitudinal and cross-sectional study arms. However, OCT scanning will be repeated up to five times within a single visit. The participants will be requested to repeat the visual field and OCT scanning in up to 5 additional independent visits within a month to minimize the possibility that an actual change in ocular structures has occurred. Duration of each additional visit will be up to 45 minutes. | |
| Alzheimer's Disease (AD) Sub-Study | Participants with AD or mild cognitive impairment (MCI) undergo the same comprehensive ocular examination as in the longitudinal and cross-sectional study arms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Show Evidence of Glaucoma Progression
The purpose of this research is to Participants who show evidence of glaucoma progression are classified as "progressors." Participants who show evidence of glaucoma progression are classified as "progressors."
Measured: Up to Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study start1 Aug 2000
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Joel S Schumann, MD, Study chair, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286637
- Sponsor's protocol ID
- 2023-37 - R01EY013178
- Other IDs
- R01EY013178
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2006
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 18657796Gabriele 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.
PubMed 18515577
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Diagnostics for Ocular Structure
- ClinicalTrials.gov ID
- NCT00286637
- Acronym / sponsor ID
- 2023-37 - R01EY013178
- Conditions
- Glaucoma, Macular Disease
- Keywords
- OCT, CSLO, SLP, Perimetry, electrophysiology, glaucoma, macular degeneration, retinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Aug 2000 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Alzheimer's 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 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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Study | – | –Subjects will undergo a comprehensive ocular examination at every visit. Frequency of the visits is dictated by the treating physician, disregarding participation in the study. In glaucoma clinic patients are typically scheduled for visits every six months, and the frequency of visits varies according to clinical severity in the retina clinic. No additional research visits are required beyond the clinically dictated schedule. |
| Longitudinal Study | – | –Subjects will undergo a comprehensive ocular examination at every visit. Frequency of the visits is dictated by the treating physician, disregarding participation in the study. In glaucoma clinic patients are typically scheduled for visits every six months, and the frequency of visits varies according to clinical severity in the retina clinic. No additional research visits are required beyond the clinically dictated schedule. |
| Reproducibility Study | – | –Subjects willing to participate in the reproducibility arm of the project will undergo the same comprehensive ocular examination as in the longitudinal and cross-sectional study arms. However, OCT scanning will be repeated up to five times within a single visit. The participants will be requested to repeat the visual field and OCT scanning in up to 5 additional independent visits within a month to minimize the possibility that an actual change in ocular structures has occurred. Duration of each additional visit will be up to 45 minutes. |
| Alzheimer's Disease (AD) Sub-Study | – | –Participants with AD or mild cognitive impairment (MCI) undergo the same comprehensive ocular examination as in the longitudinal and cross-sectional study arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study aims to enroll healthy volunteers and subjects with glaucoma, age related macular degeneration (AMD), diabetic retinopathy (DR), and central serous chorioretinopathy (CSCR). Participants with AD and MCI will be recruited as part of a sub-study.
Key inclusion criteria (4 listed)
- Ability to provide informed consent and to understand the study procedures
- Healthy volunteers
- Age related macular degeneration (AMD), diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects
- (AD Sub-Study ONLY): Subjects diagnosed with AD or MCI.
Key exclusion criteria (4 listed)
- Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
- Strabismus, nystagmus, or any condition that prevents fixation.
- Presence of any media opacities that hinders clinical view of the fundus, and any intraocular non-glaucomatous abnormality
- History of ocular trauma or intraocular surgery other than uncomplicated glaucoma interventions or cataract extraction at least 3 months previous to participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants who Show Evidence of Glaucoma Progression
Time frame: Up to Year 5
The purpose of this research is to Participants who show evidence of glaucoma progression are classified as "progressors." Participants who show evidence of glaucoma progression are classified as "progressors."
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 18657796Mumcuoglu 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.
- Derived from this study: PubMed 18515577Gabriele 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel S Schumann, MD study chair
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Macular Disease, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor Harwood (215-928-3197, tharwood@willseye.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Show Evidence of Glaucoma Progression (time frame: Up to Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00286637, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.