A Snapshot Adaptive Optics and Hyperspectral Autofluorescence Fundus Camera for Age-Related Macular Degeneration (AMD)

February 20, 2026 updated by: Roland Theodore Smith, MD, PhD, Icahn School of Medicine at Mount Sinai

Snapshot 3D Ultra-high-resolution OCT and Hyperspectral AF of In-vivo Retina

This study proposes to use a new instrument (AO-OCT/AF: adaptive optics - optical coherence tomography/autofluorescence) combined with a data processing method to image the retinal pigment epithelium (RPE) of the eye in normal subjects and in subjects with age-related macular degeneration. (AMD). While currently there is no cure, with early diagnosis, vision loss can be slowed. The technology being developed for this project will be the first imaging modality that can provide both structural and molecular information about the retina in vivo and in 3D.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

An imaging modality that allows for fast, simultaneous, noninvasive probing of both 3D cellular resolution retinal morphology by optical coherence tomography (OCT) and molecular-specific functions by autofluorescence (AF) could substantially improve both basic understanding and the early diagnosis of age-related macular degeneration (AMD), the leading cause of blindness in the developed world. The evaluation and management of AMD utilize several investigation modalities, but advancements in OCT technology have significantly contributed to better understanding of the disease, and have helped with monitoring progression and therapeutic efficacy. However, due to optical aberrations of the eye, the transverse resolution of conventional OCT is generally limited to 10-15 µm, restricting its use to visualize individual retinal cells in vivo. The integration of adaptive optics (AO) into OCT has demonstrated an immense success in mitigating these aberrations. Among various AO-OCT techniques, computation-based AO (CAO) becomes the spotlight of research because it shows unique advantages in data postprocessing flexibility and a reduced system cost. However, CAO is extremely sensitive to phase stability. The rapid motion of the eye can easily scramble the phase of reflected photons, restricting imaging to a single en-face layer.

To overcome this problem, the study team will integrate a snapshot hyperspectral imaging method, Image Mapping Spectrometry (IMS), with full-field spectral-domain OCT. The integrated system will first enable 3D CAO imaging of the retina because the single camera exposure (4 s),is too fast for eye movement to scramble phase between layers. Next, to improve resolution in 3D, the study team will adapt an established CAO algorithm to correct for wavefront aberrations. The resultant method, which the study team terms snapshot ultra-high-resolution OCT, will allow an acquisition of a quarter million A-scans simultaneously. Given a typical flash illumination duration (4us), the equivalent A-scan rate is 62.5 GHz, which is approximately three orders of magnitude faster than the state-of-the-art methods. Furthermore, to expand the system's functionality to molecular imaging, the study team will add a second IMS imaging channel for simultaneous hyperspectral imaging of retinal pigment epithelium (RPE) AF, enabling spectral biopsy of RPE and subRPE lesions such as drusen, the hallmark lesion of early AMD. The resultant dual-channel AO-OCT/AF system will be the first imaging modality that can provide both structural and molecular information about the retina in vivo and in 3D. The study team envisions such a system would shift the landscape of AMD evaluation and management. The insights so obtained will be of high value in clinical diagnosis and treatment. In addition, such a system will accelerate translational research with sensitive and early outcome testing of prospective therapeutic agents, saving sight and thereby providing enormous benefit to society.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary of Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from referring physicians of the faculty practice of New York Eye and Ear Infirmary of Mount Sinai

Description

Inclusion Criteria:

  • Patients must be aged 60 and over and pseudophakic, with clear posterior capsule and dilation to 6mm.
  • Patients must be diagnosed early/intermediate AMD in at least one eye (the study eye) with soft drusen or reticular pseudodrusen in the macula.

Exclusion Criteria:

  • Retinopathy other than AMD.
  • Inability to give informed consent
  • Bilateral advanced AMD
  • Allergy to dilation eye drops

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normals
Imaging normal subjects for equipment refinement
Diagnostic test: adaptive optics AO-OCT/AF instrument
Using the new adaptive optics AO-OCT/AF instrument, the study team will image 10 normal subjects in order to optimize image acquisition and interpretation.
Other Names:
  • Normals
Diagnostic test: adaptive optics AO-OCT/AF instrument
Using the new adaptive optics AO-OCT/AF instrument, the study team will image 40 adult subjects with age-related macular degeneration (AMD) who have non-neovascular AMD and soft drusen or subretinal drusenoid deposits in the macula.
Other Names:
  • AMD
Subjects with AMD
Imaging subjects with AMD
Diagnostic test: adaptive optics AO-OCT/AF instrument
Using the new adaptive optics AO-OCT/AF instrument, the study team will image 10 normal subjects in order to optimize image acquisition and interpretation.
Other Names:
  • Normals
Diagnostic test: adaptive optics AO-OCT/AF instrument
Using the new adaptive optics AO-OCT/AF instrument, the study team will image 40 adult subjects with age-related macular degeneration (AMD) who have non-neovascular AMD and soft drusen or subretinal drusenoid deposits in the macula.
Other Names:
  • AMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excitation spectra
Time Frame: 3 years
Excitation spectra of the retinal tissue at or near 436 nm, which will be considered representative of drusen or drusenoid material
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emission spectra
Time Frame: 3 years
Emission spectra of the retinal tissue at or near 510 nm, which will be considered representative of drusen or drusenoid material
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

University of California, Los Angeles
National Eye Institute (NEI)

Investigators

  • Principal Investigator: Ronald Theodore Smith, MD, PhD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-1999
  • 1R01EY029397-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results of the study will be shared as publications in peer-reviewed journals and at scientific meetings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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