Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera

Sponsor

Mantis Photonics AB (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05566626

Collaborator

Sundets Ögonläkare (Other)

120

Enrollment

Location

Arm

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Eye Macular Degeneration Macula Abnormality Retinal Detachment	Device: Hyperspectral retinal image Drug: Mydriacyl Ophthalmic Product	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Alle participants, both healthy subjects and patients, receive the same intervention: hyperspectral image with Mantis Photonics cameraAlle participants, both healthy subjects and patients, receive the same intervention: hyperspectral image with Mantis Photonics camera

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Camera test group The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.	Device: Hyperspectral retinal image Hyperspectral image of both eyes Other Names: hyperspectral retinoscopy Drug: Mydriacyl Ophthalmic Product Mydriatic drops before retinoscopy

Arm

Intervention/Treatment

Experimental: Camera test group

The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.

Device: Hyperspectral retinal image

Hyperspectral image of both eyes

Other Names:

hyperspectral retinoscopy

Drug: Mydriacyl Ophthalmic Product

Mydriatic drops before retinoscopy

Outcome Measures

Primary Outcome Measures

Performance evaluation - Retinal Oxygenation [During the procedure (retinoscopy with hyperspectral camera).]
Measurement of retinal oxygenation for each patient: hemoglobin oxygenation of retinal artery [in percent] hemoglobin oxygenation of retinal vein [in percent] Measurement: calculated result based on the hyperspectral reflectance profile of vein and artery regions of the retina.

Secondary Outcome Measures

Retinal examination exploration - detection of macular degeneration [After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.]
Measurement: Evaluation of spatial uniformity of spectral images. Observation of 'spots' and features apart from vascular features and optical nerve in single-frequency slices of the hyperspectral cube (notably between 550 and 600 nm) can indicate retinal and macular degeneration before this is observable with other means. Measurement is the expert evaluation of the single frequency slices for abnormalities.

Other Outcome Measures

Adverse effect [Immediately after the retinoscopy procedure.]
Measurement: Percentage of patients who report adverse effects such as transient 'imprint' of the flash or other adverse effects.
Serious adverse effect [Immediately after the retinoscopy procedure.]
Occurrence of serious adverse effects due to procedure Any patient who suffers serious harm due to procedure is a study outcome and a study endpoint.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Age >18 years.
Without known eye disease.
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:

Patients with narrow angle glaucoma
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:
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.