Clinical trial NCT05566626: Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera
Official title: A Single Centre, Controlled, Investigation to Evaluate the Performance of the Hyperspectral Camera for Retinal Non-invasive Examination Through the Observation of Retinal Oxygenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma Eye
Macular Degeneration
Macula Abnormality
Retinal Detachment
Keywords: hyperspectral
retinoscopy
oxygenation
non-invasive
Lead sponsor: Mantis Photonics AB
Sponsor class: INDUSTRY
Collaborators: name: Sundets Ögonläkare
First posted: 2022-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Alle participants, both healthy subjects and patients, receive the same intervention: hyperspectral image with Mantis Photonics camera
Primary purpose: DIAGNOSTIC

Brief summary: An explorative study of the Mantis Photonics hyperspectral camera for retinal imaging and estimation of retinal oxygenation.

Primary objective: To evaluate the performance of the hyperspectral camera for non-invasive retinal examination in order to improve the diagnosis of diseases affecting the retina or central nervous system. Secondary objective: To investigate the possibilities of the use of a hyperspectral camera for non-invasive retinal examination.

Detailed description: In the retina, light is captured and then transported via the optic nerve to the brain. Common diseases in the retina are glaucoma, diabetes and age-related changes in the macular area. Diagnosing these diseases is important to be able to treat them in time. Currently, it is possible to image the retina with, for example, a regular camera or with ultrasound. Similarly, with Optical Coherence Tomography (OCT) one can get a deep view of the layers of the retina. It is currently difficult to investigate the oxygenation level of the retina. With intravenous injection followed by photography, images can be collected of the retina that shows areas of non-perfusion. However, injecting a drug is not always possible and is also associated with risk.

Mantis Photonics AB has developed a new diagnostic camera that uses an ordinary camera's light flash but analyses the reflected light with a novel patented technology into different wavelengths allowing hyperspectral imaging (HI). With HI it is possible to capture and see changes that are not visible with a regular camera. Interpretation of the reflected spectrum allows assessment of retinal oxygenation. The oxygenation level is affected in several retinal diseases, such as diabetes and glaucoma. Initial reports have shown that the technology could be valuable for early detection of, for example, diabetic retinopathy. Furthermore, hyperspectral imaging can be used to detect molecular changes seen in age-related macular degeneration.

It is believed that hyperspectral technology can provide detailed information about various disease states in the retina, such as haemorrhages, ischemia, diabetes, and glaucoma. With improved examination technology, it is possible to sharpen treatment and perhaps advance adequate treatment. This project aims to investigate, explore and refine hyperspectral camera technology by photographing healthy retinas. Furthermore, the project intends to examine people with retinal diseases such as glaucoma and age-related macular changes, diabetes, retinal detachment and compare diagnostic accuracy with other available techniques.

Eligibility criteria: For inclusion in the investigation, the patient-subjects must fulfill all of the below criteria prior to enrollment: 1. Age \> 18 years. 2. Ophthalmological disease, disorder, illness or problem involving the retina 3. Provision of informed consent i.e., subject must be able to understand and sign the patient information and consent form. For inclusion in the investigation, the healthy subjects must fulfill all of the below criteria prior to enrollment:

1. Age \>18 years.
2. Without known eye disease.
3. Provision of informed consent i.e., subject must be able to understand and sign the patient information and consent form.

Patients-subjects who meet any of the below criteria will be excluded from the investigation:

1. Patients with narrow angle glaucoma
2. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the Principal Investigator. Healthy subjects who meet any of the below criteria will be excluded from the investigation:

1. Presence of eye disease, eye trauma, diabetes or pregnancy. 3. Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the Principal Investigator.

Primary outcomes:
measure: Performance evaluation - Retinal Oxygenation
timeFrame: During the procedure (retinoscopy with hyperspectral camera).
Secondary outcomes:
measure: Retinal examination exploration - detection of macular degeneration
timeFrame: After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.
Other outcomes:
measure: Adverse effect
timeFrame: Immediately after the retinoscopy procedure.
measure: Serious adverse effect
timeFrame: Immediately after the retinoscopy procedure.
Locations:
city: Helsingborg
country: Sweden
facility: Sundets Ögonläkare
state: Skåne Län
Study officials:
affiliation: Sundets Ögonläkare
name: Madeleine Selvander, MD
role: PRINCIPAL_INVESTIGATOR
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