Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes (AR)

September 15, 2026 updated by: Jaeb Center for Health Research
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center Corporation
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Pittsburgh Clinical Trial Consortium
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals must meet all of the inclusion criteria and none of the exclusion criteria to be eligible to participate in the study. The potential study participant must have at least one eye meeting the inclusion criteria, but participants may have both eyes eligible for the study

Description

Key Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients
  • Best corrected visual acuity 20/32 or better (Snellen) (≥74 ETDRS letters)
  • Meets criteria for one of the defined observational groups below
  • Able and willing to provide informed consent

Key Exclusion Criteria:

  • Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina
  • Previous treatment of any kind for diabetic retinopathy or DME
  • Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
  • History of rhegmatogenous retinal detachment or macular hole
  • History of vitrectomy
  • Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
  • Requiring treatment for DR/DME in the next 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-diabetic controls
Aged-matched people without a diagnosis of diabetes. At least one eye must be eligible without retinal pathology.
Diagnostic test: Visual Acuity
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
Other Names:
  • Early treatment diabetic retinopathy study visual acuity ETDRS
Diagnostic test: Reading Speed
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
  • MNREAD (Minnesota Low-Vision Reading)
Diagnostic test: Visual Field testing
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
Other Names:
  • objectiveFIELD analyzer
Diagnostic test: Contrast sensitivity
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
Other Names:
  • AST Manifold qCSF
Diagnostic test: Electroretinography (ERG) and pupillography in light- and dark-adapted states
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
Other Names:
  • RETeval device
Diagnostic test: Ultrawide field-color photograph
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
Other Names:
  • UWF-Photo
Diagnostic test: Ultrawide field-Fluorescein angiogram
a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
Other Names:
  • UWF-FA
Diagnostic test: Optical coherence tomography
non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
Other Names:
  • OCT
Other: Optical coherence tomography- Angiography
non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
Other Names:
  • OCT-A
Subclinical (No diabetic retinopathy on the diabetic retinopathy severity scale)
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 10, and no diabetic macular edema. Lower limit on duration of disease for Type 1 is 5 years, for Type 2 is 1 year
Diagnostic test: Visual Acuity
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
Other Names:
  • Early treatment diabetic retinopathy study visual acuity ETDRS
Diagnostic test: Reading Speed
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
  • MNREAD (Minnesota Low-Vision Reading)
Diagnostic test: Visual Field testing
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
Other Names:
  • objectiveFIELD analyzer
Diagnostic test: Contrast sensitivity
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
Other Names:
  • AST Manifold qCSF
Diagnostic test: Electroretinography (ERG) and pupillography in light- and dark-adapted states
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
Other Names:
  • RETeval device
Diagnostic test: Ultrawide field-color photograph
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
Other Names:
  • UWF-Photo
Diagnostic test: Ultrawide field-Fluorescein angiogram
a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
Other Names:
  • UWF-FA
Diagnostic test: Optical coherence tomography
non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
Other Names:
  • OCT
Other: Optical coherence tomography- Angiography
non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
Other Names:
  • OCT-A
Minimal to Mild non-proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 20-35, and no center-involved diabetic macular edema
Diagnostic test: Visual Acuity
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
Other Names:
  • Early treatment diabetic retinopathy study visual acuity ETDRS
Diagnostic test: Reading Speed
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
  • MNREAD (Minnesota Low-Vision Reading)
Diagnostic test: Visual Field testing
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
Other Names:
  • objectiveFIELD analyzer
Diagnostic test: Contrast sensitivity
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
Other Names:
  • AST Manifold qCSF
Diagnostic test: Electroretinography (ERG) and pupillography in light- and dark-adapted states
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
Other Names:
  • RETeval device
Diagnostic test: Ultrawide field-color photograph
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
Other Names:
  • UWF-Photo
Diagnostic test: Ultrawide field-Fluorescein angiogram
a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
Other Names:
  • UWF-FA
Diagnostic test: Optical coherence tomography
non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
Other Names:
  • OCT
Other: Optical coherence tomography- Angiography
non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
Other Names:
  • OCT-A
Moderate non-proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 43-47, and no center-involved diabetic macular edema
Diagnostic test: Visual Acuity
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
Other Names:
  • Early treatment diabetic retinopathy study visual acuity ETDRS
Diagnostic test: Reading Speed
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
  • MNREAD (Minnesota Low-Vision Reading)
Diagnostic test: Visual Field testing
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
Other Names:
  • objectiveFIELD analyzer
Diagnostic test: Contrast sensitivity
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
Other Names:
  • AST Manifold qCSF
Diagnostic test: Electroretinography (ERG) and pupillography in light- and dark-adapted states
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
Other Names:
  • RETeval device
Diagnostic test: Ultrawide field-color photograph
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
Other Names:
  • UWF-Photo
Diagnostic test: Ultrawide field-Fluorescein angiogram
a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
Other Names:
  • UWF-FA
Diagnostic test: Optical coherence tomography
non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
Other Names:
  • OCT
Other: Optical coherence tomography- Angiography
non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
Other Names:
  • OCT-A
Severe non-proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale = 53, and no center-involved diabetic macular edema
Diagnostic test: Visual Acuity
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
Other Names:
  • Early treatment diabetic retinopathy study visual acuity ETDRS
Diagnostic test: Reading Speed
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
  • MNREAD (Minnesota Low-Vision Reading)
Diagnostic test: Visual Field testing
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
Other Names:
  • objectiveFIELD analyzer
Diagnostic test: Contrast sensitivity
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
Other Names:
  • AST Manifold qCSF
Diagnostic test: Electroretinography (ERG) and pupillography in light- and dark-adapted states
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
Other Names:
  • RETeval device
Diagnostic test: Ultrawide field-color photograph
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
Other Names:
  • UWF-Photo
Diagnostic test: Ultrawide field-Fluorescein angiogram
a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
Other Names:
  • UWF-FA
Diagnostic test: Optical coherence tomography
non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
Other Names:
  • OCT
Other: Optical coherence tomography- Angiography
non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
Other Names:
  • OCT-A
Proliferative diabetic retinopathy
Eyes of patients with a diagnosis of diabetes, Diabetic Retinopathy Severity Scale > 60, and no center-involved diabetic macular edema
Diagnostic test: Visual Acuity
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
Other Names:
  • Early treatment diabetic retinopathy study visual acuity ETDRS
Diagnostic test: Reading Speed
The MNREAD (Minnesota Low-Vision Reading) test is a standardized test that measures reading performance in people with normal or impaired vision.
Other Names:
  • MNREAD (Minnesota Low-Vision Reading)
Diagnostic test: Visual Field testing
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
Other Names:
  • objectiveFIELD analyzer
Diagnostic test: Contrast sensitivity
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
Other Names:
  • AST Manifold qCSF
Diagnostic test: Electroretinography (ERG) and pupillography in light- and dark-adapted states
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
Other Names:
  • RETeval device
Diagnostic test: Ultrawide field-color photograph
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
Other Names:
  • UWF-Photo
Diagnostic test: Ultrawide field-Fluorescein angiogram
a high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
Other Names:
  • UWF-FA
Diagnostic test: Optical coherence tomography
non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
Other Names:
  • OCT
Other: Optical coherence tomography- Angiography
non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
Other Names:
  • OCT-A

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Does the performance of the objectiveFIELD Analyzer at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
The objectiveFIELD Analyzer is a perimetry tool that measures visual fields using electroencephalography-based brain responses to flickering light. Higher sensitivity = better function, Lower sensitivity (more negative deviations from normal) = worse function; Global indices (MD, PSD-like values) indicate overall field loss and pattern of damage.
4 Years
Does the performance of the Contrast sensitivity (AST Manifold qCSF) at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
A clinical device that utilizes the quick Contrast Sensitivity Function (qCSF) methodology to assess visual function. The qCSF method is a Bayesian adaptive algorithm designed to efficiently estimate a patient's contrast sensitivity across a wide range of spatial frequencies. Higher curve / higher AULCSF = better contrast sensitivity (normal vision). Lower curve / lower Area Under the Log Contrast Sensitivity Function = reduced contrast sensitivity (seen in early AMD, glaucoma, diabetic retinopathy, etc.).
4 Years
Does the performance of the Electroretinography (ERG) at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
The RETeval® is a portable, handheld electroretinography (ERG) and visual evoked potential (VEP) device. It enables clinicians to assess the retinal and optic nerve.
4 Years
Does the performance of the Ultrawide field-color photograph at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
Ultrawide field color photography is a high-resolution, wide-angle retinal imaging technique that captures both central and peripheral retina in natural color. Grading is typically based on the Diabetic Retinopathy Severity Scale or DRSS, which is a standardized grading scale from 10 (no DR) to 85 (severe PDR)
4 Years
Does the performance of the Ultrawide field-Fluorescein angiogram at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
A high-resolution, wide-angle retinal vascular imaging technique that allows clinicians to see both central and peripheral retina blood flow, detect ischemia, leakage, and neovascularization, and guide diagnosis and treatment
4 Years
Does the performance of the Optical coherence tomography at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
A non-invasive retinal imaging tool that produces detailed cross-sectional images. Disease-specific grading systems (like macular thickness for DME or RNFL thickness for glaucoma) are used to quantify severity and monitor progression
4 Years
Does the performance of the Optical Coherence Tomography- Angiography at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
A non-invasive, dye-free imaging method that maps retinal and choroidal vasculature, allowing both qualitative and quantitative assessment of microvascular health. Quantitative metrics like vessel density, perfusion, FAZ size, and non-perfusion area serve as functional "scales" for disease severity and progression.
4 Years
Does the performance of Visual Acuity at baseline worsen as the Diabetic Retinopathy Severity Score increases
Time Frame: 4 Years
Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity
4 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jaeb Center for Health Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Eye Institute (NEI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol AR
  • UG1EY014231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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