Adaptive Optics for Ophthalmic Technologies

NCT02826655 | Terminated

• 1 other identifier: Pro00071278
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Keywords

WF-OCT; OCT; diabetic retinopathy; diabetic macular edema

Outcome Measures

Primary Outcomes (2)

• Image Quality

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

  30 minutes

• 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.

  30 minutes

Study Arms (2)

Healthy Controls

ACTIVE COMPARATOR

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

Subjects with diabetic retinopathy

EXPERIMENTAL

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

Interventions

WF-AO-OCT DEVICE

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.

Healthy Controls; Subjects with diabetic retinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant media opacity (e.g. cataract or vitreous hemorrhage) precluding clinical imaging adequate for interpretation
• Unwilling or unable to provide legally effective written consent

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Sina Farsiu, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 11, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

US (1)