Structure and Function of Retinal Disease
- Conditions
- Retinal Toxicity
- Interventions
- Device: Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Retinal disease of either inherited retinal degeneration or retinal toxicity
- Ocular media opacities
- High refractive error
- Pupil dilation imposes a risk to ocular health
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Retinal Disease Adaptive Optics - Optical Coherence Tomography (AO-OCT) retinal imaging 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.
- Primary Outcome Measures
Name Time Method 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).
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Indiana University School of Optometry
🇺🇸Bloomington, Indiana, United States