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Diabetic RetinopathyNCT02826655

Adaptive Optics for Ophthalmic Technologies

A study testing WF-AO-OCT in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Retinopathy, Diabetic Macular Edema
What is being tested?
WF-AO-OCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Jun 2016to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Diagnosis of diabetic retinopathy in one or both eyes
  • Men and Women, aged 18 years or older
  • Able to provide written informed consent
  • No history of retinal disease in one or both eyes
  • Men and Women, aged 18 years or older
  • Able to provide written informed consent
Show all 9Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Eye Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the 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.

Being tested
WF-AO-OCT
Keywords
WF-OCT, OCT, diabetic retinopathy, diabetic macular edema
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WF-AO-OCTDevice

    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.

Study groups in NCT02826655
Study groupRoleWhat they receive
Healthy ControlsActive comparatorStudy 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.
Receives: Device: WF-AO-OCT
Subjects with diabetic retinopathyExperimentalStudy 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.
Receives: Device: WF-AO-OCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Image Quality

    Assessment of quality of images obtained by WF-AO-OCT unit.

    Measured: 30 minutes

  2. Peripheral Retina Structure Differences between Healthy Controls and participants with diabetic retinopathy.

    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.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Why it stopped: lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02826655
Sponsor's protocol ID
Pro00071278
Status last verified
Sep 2020
First submitted
1 Jul 2016
Last updated
23 Sep 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing WF-AO-OCT in people with Diabetic Retinopathy and Diabetic Macular Edema, run by Duke University 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 9 inclusion and 0 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: stopped early, as of the sponsor's last update on 23 Sep 2020. 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?

The study was stopped early (reason given: lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image Quality (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Sep 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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