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

NCT03963817 | Active Not Recruiting

• 2 other identifiers: GCO 17-19991R01EY029397-01A1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age Related Macular Degeneration

Keywords

Imaging; Autofluorescence imaging; Spectral domain optical coherence tomography; Adaptive optics; Soft drusen; Reticular pseudodrusen

Outcome Measures

Primary Outcomes (1)

• Excitation spectra

  Excitation spectra of the retinal tissue at or near 436 nm, which will be considered representative of drusen or drusenoid material

  3 years

Secondary Outcomes (1)

• Emission spectra

  3 years

Study Arms (2)

Normals

Imaging normal subjects for equipment refinement

Diagnostic Test: adaptive optics AO-OCT/AF instrument

Subjects with AMD

Imaging subjects with AMD

Diagnostic Test: adaptive optics AO-OCT/AF instrument

Interventions

adaptive optics AO-OCT/AF instrument DIAGNOSTIC_TEST

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.

Also known as: Normals

Normals

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of California, Los Angeles: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (1)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Related Publications (1)

• Gao L, Smith RT, Tkaczyk TS. Snapshot hyperspectral retinal camera with the Image Mapping Spectrometer (IMS). Biomed Opt Express. 2012 Jan 1;3(1):48-54. doi: 10.1364/BOE.3.000048. Epub 2011 Dec 7.

  PMID: 22254167 BACKGROUND

Related Links

• Snapshot hyperspectral retinal camera with the Image Mapping Spectrometer (IMS) publication

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Ronald Theodore Smith, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: September 6, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)