Snapshot Camera for AMD

Age Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963817
• Other study ID #: GCO 17-1999
• Secondary ID: 1R01EY029397-01A
• Status: Recruiting
• Start date: September 6, 2023
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Katy Tai
• Phone: 212-979-4251
• Email: ktai[@]nyee.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary of Mount Sinai	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Eye Institute (NEI), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emission spectra	Emission spectra of the retinal tissue at or near 510 nm, which will be considered representative of drusen or drusenoid material	3 years

External Links

•   Mount Sinai Clinical Trials Website