Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT06860568
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2025-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The GA in HSI Study
Sponsor:
Optina Diagnostics Inc.
Organization:
Study Overview
Official Title:
Annotation of Geographic Atrophy in Hyperspectral Images Captured With the Optina-4C™
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study used a retrospective dataset collected by Optina under different study protocols. The target study population will include adults over the age of 50 years, with and without the presence of AMD.
Detailed Description:
This retrospective, case-control study used the clinical data previously collected by Optina (CIP 22-003 AND Study, CIP 22-004 CAS Training Study and RWD 24-011 RWD Study). As such, no new participants were enrolled for this study. The review and annotation of the MHRC H5 Images for GA are within the scope of each of these studies and the study participants have provided their Informed Consent for use of their retinal scans to assess clinical diagnostic applications. Images from the above-mentioned studies that met the inclusion criteria (there were no exclusion criteria) were classified into 3 different cohorts per the selection process described in the Study Protocol. Each cohort required a minimum of 10 MHRC Images from unique eyes with matched OCT scans.
* Cohort A: Eyes of patients with a diagnosis of dry AMD with GA lesions:
o This cohort included patients with intermediate-or late-stage dry AMD where GA lesions are present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
* Cohort B: Eyes of patients with diagnosis of dry AMD without the presence of GA lesions
o This cohort included patients with early or intermediate dry AMD where GA lesions are not present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
* Cohort C: Eyes of age-matched healthy patients (no AMD or GA lesions)
* This cohort included patients with healthy retinas, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst. Knowledge Transfer and Training Optina facilitated a Knowledge Transfer and Training session by the IOI for CapeStart Study Personnel.
CapeStart Study Personnel were trained in using Optivizon Viewing Software, the viewing software included in the marketed version of Optina-4C (MHRC device), and the Optina Segmentation tool.
Additionally, they were trained in the presentation of GA in HSI Images. Evaluation Phase CapeStart were provided with the Test Dataset of eye scans (n=40 eyes). CapeStart Optometristsreviewed all the HSI Images from the Optina-4C in Optivizon, annotated any GA lesions (if present) in the RelSpec@560 image using the Optina Segmentation tool, and completed the HSI Questionnaire for the MHRC H5 Images. Annotation Process The HSI RelSpec@560 Images were annotated by the CapeStart Optometrists for the Evaluation Phase.
The annotations were completed using the validated Optina Segmentation Tool per the User Manual, and all image annotations were performed on the Virtual Machine established and validated by Optina for this study.
If the eye was considered to have at least one GA lesion after viewing the MHRC H5 Images in Optivizon, the RelSpec@560 Image was annotated using the Optina Segmentation Tool. The annotator used the yellow label for high confidence level for GA visualization and Blue label for low confidence level.
Reference Data The IOI was responsible for generating the reference data. The IOI reviewed all OCT images as well as the MHRC H5 Images, then annotated the RelSpec@560 images. The IOI visual assessment made note of all cRORA (GA lesions) and iRORA (nascent GA lesion) in the OCT and aligned where possible with corresponding lesions in the HSI images. Lastly, the IOI completed the HSI Questionnaire for all annotated Relspec images.
* Cohort A: Eyes of patients with a diagnosis of dry AMD with GA lesions:
o This cohort included patients with intermediate-or late-stage dry AMD where GA lesions are present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
* Cohort B: Eyes of patients with diagnosis of dry AMD without the presence of GA lesions
o This cohort included patients with early or intermediate dry AMD where GA lesions are not present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
* Cohort C: Eyes of age-matched healthy patients (no AMD or GA lesions)
* This cohort included patients with healthy retinas, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst. Knowledge Transfer and Training Optina facilitated a Knowledge Transfer and Training session by the IOI for CapeStart Study Personnel.
CapeStart Study Personnel were trained in using Optivizon Viewing Software, the viewing software included in the marketed version of Optina-4C (MHRC device), and the Optina Segmentation tool.
Additionally, they were trained in the presentation of GA in HSI Images. Evaluation Phase CapeStart were provided with the Test Dataset of eye scans (n=40 eyes). CapeStart Optometristsreviewed all the HSI Images from the Optina-4C in Optivizon, annotated any GA lesions (if present) in the RelSpec@560 image using the Optina Segmentation tool, and completed the HSI Questionnaire for the MHRC H5 Images. Annotation Process The HSI RelSpec@560 Images were annotated by the CapeStart Optometrists for the Evaluation Phase.
The annotations were completed using the validated Optina Segmentation Tool per the User Manual, and all image annotations were performed on the Virtual Machine established and validated by Optina for this study.
If the eye was considered to have at least one GA lesion after viewing the MHRC H5 Images in Optivizon, the RelSpec@560 Image was annotated using the Optina Segmentation Tool. The annotator used the yellow label for high confidence level for GA visualization and Blue label for low confidence level.
Reference Data The IOI was responsible for generating the reference data. The IOI reviewed all OCT images as well as the MHRC H5 Images, then annotated the RelSpec@560 images. The IOI visual assessment made note of all cRORA (GA lesions) and iRORA (nascent GA lesion) in the OCT and aligned where possible with corresponding lesions in the HSI images. Lastly, the IOI completed the HSI Questionnaire for all annotated Relspec images.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: