Structure and Function of Retinal Disease

March 10, 2026 updated by: Kristen Bowles Johnson, Indiana University
Current clinical cameras do not allow clinicians to see the cells of the retina. This study will evaluate a new electronic camera's ability to observe the human retina in finer detail.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This research study will (1) test the ability of a new electronic camera developed in Dr. Miller's laboratory to observe retina in human subjects, and (2) use the camera for observing disease in the eye. This new camera integrates cutting-edge technologies in adaptive optics (AO) and optical coherence tomography (OCT) that enable the camera to capture sharp images. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe the retina with finer resolution than current clinical cameras, and (2) whether this finer detail is useful for observing the progression of disease in the eye.

To address the second objective, the study will subjects with various disease severity of drusen associated geographic atrophy.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

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
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University School of Optometry

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Subjects will be recruited through IU school of optometry affiliated clinics, IU health clinics, or their eye care provider.

Description

Inclusion Criteria:

  • Retinal disease of either inherited retinal degeneration or retinal toxicity

Exclusion Criteria:

  • Ocular media opacities
  • High refractive error
  • Pupil dilation imposes a risk to ocular health

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

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retinal Disease
Subjects with either retinal toxicity or inherited retinal degeneration will undergo multimodal clinical imaging and Adaptive Optics Optical Coherence Tomography (AO-OCT) imaging at each study visit to document regions of disease and healthy retina over time.
Device: Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging
AO-OCT used in this study is an investigational OCT imaging system. In this instrument, ocular aberration sensing and correction is achieved with a Shack-Hartmann wavefront sensor (SHWS) and deformable mirror, respectively. A pupil camera and fixation target are used to position the participant's head and eye for scanning a particular retinal region within 15 degrees of the fovea. Data collected generally includes AO-OCT volume videos and SHWS measurements of ocular aberrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers
Time Frame: 2 years
Images of the photoreceptor and RPE cell layers taken with clinical instruments and the AO-OCT will be compared.
2 years
RPE cell morphology changes
Time Frame: 2 years
Images will be used to determine the changes in RPE cell morphology in regions of healthy and diseased retina (in subjects with retinal disease).
2 years
Cone Photoreceptor Dysfunction
Time Frame: 2 years
Images will be used to determine changes in cone photoreceptor dysfunction and death
2 years

Collaborators and Investigators

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

Sponsor

Indiana University

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)

November 1, 2022

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

February 24, 2025

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18287

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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