An interventional study of Hyperspectral retinal image and Mydriacyl Ophthalmic Product in Glaucoma Eye, Macular Degeneration and Macula Abnormality, sponsored by Mantis Photonics AB. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Mantis Photonics AB · Not applicable, Interventional, and Diagnostic
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 120 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Mantis Photonics AB is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Patients-subjects who meet any of the below criteria will be excluded from the investigation:
The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
Device: Hyperspectral retinal image · Drug: Mydriacyl Ophthalmic Product
Hyperspectral image of both eyes
Also known as: hyperspectral retinoscopy
Mydriatic drops before retinoscopy
Performance evaluation - Retinal Oxygenation
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.
Time frame: During the procedure (retinoscopy with hyperspectral camera).
Retinal examination exploration - detection of macular degeneration
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.
Time frame: After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.
Adverse effect
Measurement: Percentage of patients who report adverse effects such as transient 'imprint' of the flash or other adverse effects.
Time frame: Immediately after the retinoscopy procedure.
Serious adverse effect
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.
Time frame: Immediately after the retinoscopy procedure.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No Individual Participant Data (IPD) sharing to third parties. Data of individual participants will be used for this study only.
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mantis Photonics AB