A Single Centre, Controlled, Investigation to Evaluate the Performance of the Hyperspectral Camera for Retinal Non-invasive Examination Through the Observation of Retinal Oxygenation

MANTIS_2022_08_Oxygenation_S

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.

2022-10-01

2023-11-01

2023-12-01

120

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Alle participants, both healthy subjects and patients, receive the same intervention: hyperspectral image with Mantis Photonics camera', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2022-10-21