- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826655
Adaptive Optics for Ophthalmic Technologies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adaptive optics (AO) is an optical technique that corrects the natural aberrations (optical imperfections) of the eye. Since it was first described in 1997, it has been used successfully to enhance the visualization of retinal tissue, in particular, the human photoreceptor mosaic. Previous studies using AO in the human eye have contributed to considerable advancements in our understanding of vision and ocular pathologies.
An AO system sends a pattern of light into the eye that balances the eye's inherent imperfections. This leads to better imaging by providing better light focusing by the natural lens of the eye. The AO system measures the light returning from the eye as is typical in clinically accepted optical coherence tomography and scanning laser ophthalmoscope systems.
A schematic AO system consists of a light input, a deformable/adaptive mirror that modifies the shape of the light entering and exiting the eye, and a detector system that captures and analyzes the returning light from the eye.
The device used in this feasibility study has been tested to ensure that its light output is within ANSI limits for safe ocular exposure and is capable of obtaining useful images of the peripheral retina in normal subjects.
Diabetic retinopathy represents the most common cause of vision loss in working aged adults. Vision loss is related to two manifestations of advanced diabetic retinopathy: proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME). PDR occurs when the vascular perfusion of the retina is compromised and compensatory signals including expression of vascular endothelial growth factor causes neovascularization on the surface of the retina. These abnormal vessels cause vision loss by either bleeding into the vitreous or by contracting leading to retinal detachment. DME occurs when vascular leakage results in swelling of the macular tissue causing central vision loss. While DME affects the macula (the area typically imaged using OCT), PDR is much more frequently found in the peripheral retina which is not typically imaged by traditional OCT devices. In recently years, wide field fluorescein angiography has allowed insights into the relationship between DME, PDR and the status of retinal blood vessels within the macula and the retinal periphery. WF-AO-OCT has the potential to provide similar or complementary structural detail of the retinal tissue and vasculature within the macula and retinal periphery. The advantage of WF-AO-OCT is that it is a non-contact, non-invasive imaging technology which is easier to use, faster and less invasive compared to fluorescein angiography which entails intravenous injection of fluorescein, requires a skilled ophthalmic photographer and takes 10-20 minutes to perform. By imaging participants who have previously undergone wide field fluorescein angiography as standard of care, the investigators will be able to compare the information obtained using WF-AO-OCT and to determine its sensitivity in identifying specific vascular and morphological findings associated with PDR and DME.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Eye Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for diabetic retinopathy participants:
- Diagnosis of diabetic retinopathy in one or both eyes
- Men and Women, aged 18 years or older
- Able to provide written informed consent
Inclusion Criteria for healthy control participants:
- No history of retinal disease in one or both eyes
- Men and Women, aged 18 years or older
- Able to provide written informed consent
Exclusion Criteria for both diabetic retinopathy and healthy control participants:
- Significant media opacity (e.g. cataract or vitreous hemorrhage) precluding clinical imaging adequate for interpretation
- Unwilling or unable to provide legally effective written consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Controls
Study participants will undergo imaging of both eyes with the WF-AO-OCT unit, per standard operating protocol.
Imaging is noncontact.
Study participants will undergo only a single imaging session on a single day.
|
WF-AO-OCT allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration.
This unit is being conducted under an abbreviated IDE.
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Experimental: Subjects with diabetic retinopathy
Study participants will undergo imaging of both eyes with the WF-AO-OCT unit, per standard operating protocol.
Imaging is noncontact.
Study participants will undergo only a single imaging session on a single day.
|
WF-AO-OCT allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration.
This unit is being conducted under an abbreviated IDE.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image Quality
Time Frame: 30 minutes
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Assessment of quality of images obtained by WF-AO-OCT unit.
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30 minutes
|
Peripheral Retina Structure Differences between Healthy Controls and participants with diabetic retinopathy.
Time Frame: 30 minutes
|
Differences between the control and case populations will be described using descriptive statistics.
This data can then be used to power future, more dedicated studies.
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30 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sina Farsiu, PhD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00071278
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
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Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
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Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
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Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
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AEYE Health IncA. Stein Regulatory Affairs Consulting Ltd.RecruitingDiabetic Mellitus | Diabetic Retinopathy, DRUnited States
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Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
-
King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
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Retina Macula InstituteAllerganCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
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TherOxCompletedMyocardial InfarctionUnited States
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Arch OncologyCompletedMultiple MyelomaUnited States
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