Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study

NCT07747662 | Enrolling By Invitation FDA Device

• 3 other identifiers: 2023-0958 Sub-studyProtocol Version 4/20/2026SMPH/OPHTHAL&VIS SCI/FPRC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This research sub-study is to evaluate if combining images from Optical Coherence Tomography (OCT) scans with Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) could show a link between structural changes in the back of the eye and vision. 10 participants that were enrolled in the COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy study \[NCT05961332\] will be approached to enroll. Participants may complete OCT imaging and initial assessments during an initial visit and may return for additional procedures, including microperimetry and AOSLO imaging, within a window of up to 4 weeks.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (3)

• Incidence of Photoreceptors in EZ absent regions

  The aim is to validate the use of AOSLO imaging for OCT-based EZ classifications, directly visualizing photoreceptor mosaics and correlating EZ loss with photoreceptor structure. Semi-automated machine learning algorithms will be used to segment the EZ layer on OCT images and generate en face maps. All algorithm outputs will be reviewed and verified by trained human graders. AOSLO imaging will validate these maps by providing photoreceptor cell counts and qualitative assessments in the same region

  up to 6 hours total during one or two study visits

• Area of EZ absent regions on AOSLO vs OCT imaging

  The aim is to validate the use of AOSLO imaging for OCT-based EZ classifications, directly visualizing photoreceptor mosaics and correlating EZ loss with photoreceptor structure. Semi-automated machine learning algorithms will be used to segment the EZ layer on OCT images and generate en face maps. All algorithm outputs will be reviewed and verified by trained human graders. Graders will independently measure area of EZ loss from images of each device. The measurements (in mm²) will be compared between the two devices.

  up to 6 hours total during one or two study visits

• Correlation of Retinal Sensitivity Data with EZ Status

  The aim is to correlate structural metrics (EZ status from OCT and AOSLO) with functional data (microperimetry), establishing EZ loss as a reliable biomarker for vision loss.

  up to 6 hours total during one or two study visits

Study Arms (1)

Microperimetry, Optical Coherence Tomography, Adaptive Optics

EXPERIMENTAL

Imaging procedures may be completed during a single study visit or across two study visits based on participant availability and operational workflow. When procedures occur across two visits, OCT imaging will be performed first to allow WRC review prior to scheduling microperimetry and AOSLO imaging. If all procedures are completed during a single visit, the total visit time is approximately 5-6 hours. If a second study visit is needed, only the remaining study procedures will be completed, so the second visit will be shorter since the initial ophthalmic procedures have already been performed.

Device: Adaptive Optics Scanning Light Ophthalmoscopy; Device: Microperimetry; Device: Optical Coherence Tomography

Interventions

Adaptive Optics Scanning Light Ophthalmoscopy DEVICE

AOSLO imaging offers unprecedented resolution by correcting optical distortions, enabling direct visualization of individual photoreceptors. The procedure takes 60 minutes.

Also known as: AOSLO

Microperimetry, Optical Coherence Tomography, Adaptive Optics

Microperimetry DEVICE

Microperimetry measures retinal sensitivity at specific retinal locations while tracking eye movements, enabling precise correlation with structural changes. The procedure takes up to 45 minutes.

Microperimetry, Optical Coherence Tomography, Adaptive Optics

Optical Coherence Tomography DEVICE

OCT will be performed using the Heidelberg Spectralis system with a high-resolution scanning protocol. This is a repeat procedure, the first image was obtained in the main study. The procedure takes 5 minutes.

Also known as: OCT

Microperimetry, Optical Coherence Tomography, Adaptive Optics

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older and may be either male or female and may be of any race
• Established diagnosis of geographic atrophy (GA) due to age-related macular degeneration (AMD)
• GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude participants from participation
• Willing to participate as evidenced by signing the written informed consent
• Early-stage GA defined as
• GA area of between 1.25 mm2 and 23 mm2
• GA may be unifocal or multifocal
• GA may be subfoveal or extrafoveal
• Concurrent peripapillary atrophy will not exclude participant from participation
• Phakic and pseudophakic participants are eligible for enrollment, with phakic participants prioritized when feasible.

You may not qualify if:

• Unable to tolerate ophthalmic imaging
• Presence of neovascular AMD on optical coherence tomography (OCT) as confirmed by an ophthalmologist
• Presence of significant media opacity preventing adequate retinal imaging
• Presence of concurrent retinal disease which may confound assessment
• Ocular media opacity or other condition(s) that, in the opinion of the investigators, may preclude imaging.
• Individuals who, in the opinion of the investigator, are unable to tolerate study procedures or comply with study requirements.
• Prior or current treatment with intraocular injections for geographic atrophy (e.g., pegcetacoplan \[Syfovre\] or similar therapies) is not permitted.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Links

• COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) main study

MeSH Terms

Conditions

Geographic Atrophy

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Amitha Domalpally, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: September 29, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)