Snapshot Camera for AMD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03963817 |
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Recruitment Status :
Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : January 15, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Age Related Macular Degeneration | Diagnostic Test: adaptive optics AO-OCT/AF instrument |
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 |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Cross-Sectional |
| Official Title: | Snapshot 3D Ultra-high-resolution OCT and Hyperspectral AF of In-vivo Retina |
| Estimated Study Start Date : | February 2022 |
| Estimated Primary Completion Date : | February 2024 |
| Estimated Study Completion Date : | March 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Normals
Imaging normal subjects for equipment refinement
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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 Name: Normals |
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Subjects with AMD
Imaging subjects with AMD
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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 Name: AMD |
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963817
| Contact: Katy Tai | 212-979-4251 | ktai@nyee.edu | |
| Contact: Harriet Lloyd | 212-979-4672 | hlloyd@nyee.edu |
| United States, New York | |
| New York Eye and Ear Infirmary of Mount Sinai | |
| New York, New York, United States, 10003 | |
| Principal Investigator: | Ronald Theodore Smith, MD, PhD | Icahn School of Medicine at Mount Sinai |
| Responsible Party: | Roland Theodore Smith, Professor, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT03963817 |
| Other Study ID Numbers: |
GCO 17-1999 1R01EY029397-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | May 28, 2019 Key Record Dates |
| Last Update Posted: | January 15, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Results of the study will be shared as publications in peer-reviewed journals and at scientific meetings. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Imaging Autofluorescence imaging Spectral domain optical coherence tomography |
Adaptive optics Soft drusen Reticular pseudodrusen |
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |