Structure and Function of Retinal Disease

Not Applicable

Recruiting

• Conditions: Retinal Toxicity

• Registration Number: NCT05643157
• Lead Sponsor: Indiana University

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 image 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 collect extremely sharp volumetric images of the retina in human subjects, and (2) use the camera for addressing fundamental questions about how disease progresses 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. However, many aspects of the camera are already employed in clinical instruments used routinely by eyecare practitioners worldwide. The objective of our study is to find out (1) whether the AO-OCT camera will allow researchers to observe and quantify finer detail in the retina than current clinical cameras, and (2) whether this finer detail is useful for understanding the progression of disease in the eye.

To address the second objective, the study will look at two subgroups of retinal disease. The first is age-related macular degeneration (AMD), a leading cause of blindness in the developed world. Because this disease is difficult to study directly as it takes years to progress, we will study it indirectly using subjects with a form of retinal toxicity that exhibits a retinal phenotype similar to that of AMD but progresses on a much faster time scale. The second disease subgroup is inherited retinal degeneration that affects as many as 1 in every 2,000 people worldwide. For this subgroup, the researchers will test the exquisite sensitivity of the AO-OCT imaging system to detect minute changes in disease progression over short periods of time covering weeks and months.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of photoreceptor and retinal pigment epithelium (RPE) cell layers	2 years	Images of the photoreceptor and RPE cell layers taken with clinical instruments and the AO-OCT will be compared.
Cone Photoreceptor Dysfunction	2 years	Images will be used to determine changes in cone photoreceptor dysfunction and death
RPE cell morphology changes	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).

Trial Locations

Locations (1)

Indiana University School of Optometry; 🇺🇸 Bloomington, Indiana, United States