Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera
- Conditions
- Macular DegenerationRetinal DetachmentGlaucoma EyeMacula Abnormality
- Interventions
- Device: Hyperspectral retinal image
- Registration Number
- NCT05566626
- Lead Sponsor
- Mantis Photonics AB
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camera test group Mydriacyl Ophthalmic Product The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients. Camera test group Hyperspectral retinal image The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Sundets Ögonläkare
🇸🇪Helsingborg, Skåne Län, Sweden