A Single Centre, Controlled, Investigation to Evaluate the Performance of the Hyperspectral Camera for Retinal Non-invasive Examination Through the Observation of Retinal Oxygenation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Performance evaluation - Retinal Oxygenation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Camera test group
The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
Intervention: Hyperspectral retinal image (Device)
Camera test group
The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
Intervention: Mydriacyl Ophthalmic Product (Drug)
Outcomes
Primary Outcomes
Performance evaluation - Retinal Oxygenation
Time Frame: 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 Outcomes
- Retinal examination exploration - detection of macular degeneration(After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.)