Structure and Function of Retinal Disease

NCT ID: NCT05643157

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-02-28

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.

Conditions

Retinal Toxicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Kristen Bowles Johnson

Post Doctoral Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University School of Optometry

Bloomington, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristen Bowles Johnson, O.D.,Ph.D.

Role: CONTACT

kbowlesj@iu.edu

812-855-8991

Facility Contacts

Kristen Bowles Johnson, O.D.,Ph.D.

Role: primary

kbowlesj@iu.edu

812-855-8991

Other Identifiers

18287

Identifier Type: -

Identifier Source: org_study_id