Skip to content

Structure and Function of Retinal Disease

Structure and Function of Retinal Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05643157
Enrollment
5
Registered
2022-12-08
Start date
2022-11-01
Completion date
2025-02-24
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Toxicity

Keywords

retinal toxicity

Brief summary

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.

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.

Interventions

DEVICEAdaptive 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.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cone Photoreceptor Dysfunction2 yearsImages will be used to determine changes in cone photoreceptor dysfunction and death
Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers2 yearsImages of the photoreceptor and RPE cell layers taken with clinical instruments and the AO-OCT will be compared.
RPE cell morphology changes2 yearsImages will be used to determine the changes in RPE cell morphology in regions of healthy and diseased retina (in subjects with retinal disease).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026