Completed

NCT Number: NCT05643157

Structure and Function of Retinal Disease

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.

Completed

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Key information

Conditions

Retinal Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Optometry

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging

Device

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.

Primary outcomes

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.
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).
Cone Photoreceptor Dysfunction

Time frame: 2 years

Images will be used to determine changes in cone photoreceptor dysfunction and death

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Dec 8, 2022
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.