Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05566626
• Other study ID #: MANTIS_2022_08_Oxygenation_S
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Mantis Photonics AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma Eye
• Macula Abnormality
• Macular Degeneration
• Retinal Detachment

Intervention

Device:
• Hyperspectral retinal image
Hyperspectral image of both eyes

Drug:
• Mydriacyl Ophthalmic Product
Mydriatic drops before retinoscopy

Locations

Country	Name	City	State
Sweden	Sundets Ögonläkare	Helsingborg	Skåne Län

Sponsors (2)

Lead Sponsor	Collaborator
Mantis Photonics AB	Sundets Ögonläkare

Country where clinical trial is conducted

Sweden, 

References & Publications (8)

Bernardes R, Serranho P, Lobo C. Digital ocular fundus imaging: a review. Ophthalmologica. 2011;226(4):161-81. doi: 10.1159/000329597. Epub 2011 Sep 22. Review. — View Citation

Hardarson SH, Stefánsson E, Bek T. Retinal oxygen saturation changes progressively over time in diabetic retinopathy. PLoS One. 2021 May 12;16(5):e0251607. doi: 10.1371/journal.pone.0251607. eCollection 2021. — View Citation

Johnson WR, Wilson DW, Fink W, Humayun M, Bearman G. Snapshot hyperspectral imaging in ophthalmology. J Biomed Opt. 2007 Jan-Feb;12(1):014036. — View Citation

Lee EJ, Kee HJ, Han JC, Kee C. Evidence-based understanding of disc hemorrhage in glaucoma. Surv Ophthalmol. 2021 May-Jun;66(3):412-422. doi: 10.1016/j.survophthal.2020.09.001. Epub 2020 Sep 17. Review. — View Citation

Lu G, Fei B. Medical hyperspectral imaging: a review. J Biomed Opt. 2014 Jan;19(1):10901. doi: 10.1117/1.JBO.19.1.010901. Review. — View Citation

Meinke M, Müller G, Helfmann J, Friebel M. Empirical model functions to calculate hematocrit-dependent optical properties of human blood. Appl Opt. 2007 Apr 1;46(10):1742-53. — View Citation

Ohno-Matsui K. Parallel findings in age-related macular degeneration and Alzheimer's disease. Prog Retin Eye Res. 2011 Jul;30(4):217-38. doi: 10.1016/j.preteyeres.2011.02.004. Epub 2011 Mar 25. Review. — View Citation

Safi H, Safi S, Hafezi-Moghadam A, Ahmadieh H. Early detection of diabetic retinopathy. Surv Ophthalmol. 2018 Sep - Oct;63(5):601-608. doi: 10.1016/j.survophthal.2018.04.003. Epub 2018 Apr 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effect	Measurement: Percentage of patients who report adverse effects such as transient 'imprint' of the flash or other adverse effects.	Immediately after the retinoscopy procedure.
Other	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.	Immediately after the retinoscopy procedure.
Primary	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.	During the procedure (retinoscopy with hyperspectral camera).
Secondary	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.	After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.