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Adaptive Optics for Ophthalmic Technologies

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ClinicalTrials.gov Identifier: NCT02826655
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This is a feasibility study to assess the use of wide field adaptive optics optical coherence tomography (WF-AO-OCT) to determine whether there are structural differences in the peripheral retina in participants diagnosed with diabetic retinopathy compared to a healthy control group. This study being conducted under an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks related to light exposure will be managed by ensuring that the exposure to the WF-AO-OCT light source is well below maximum permissible limits for safe exposure.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Diabetic Macular Edema Device: WF-AO-OCT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Adaptive Optics for Ophthalmic Technologies
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.
Device: WF-AO-OCT
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.

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.
Device: WF-AO-OCT
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.




Primary Outcome Measures :
  1. Image Quality [ Time Frame: 30 minutes ]
    Assessment of quality of images obtained by WF-AO-OCT unit.

  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826655


Contacts
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Contact: Sina Farsiu, PhD 919-684-6642
Contact: Michael Allingham, MD, PhD 919-684-9010

Locations
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United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ana Garcia-Turner    919-681-8872      
Principal Investigator: Sina Farsiu, PhD         
Sub-Investigator: Michael Allingham, MD, PhD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Sina Farsiu, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02826655     History of Changes
Other Study ID Numbers: Pro00071278
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Keywords provided by Duke University:
WF-OCT
OCT
diabetic retinopathy
diabetic macular edema

Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases