Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera
NCT ID: NCT05566626
Last Updated: 2022-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-10-31
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Camera test group
The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
Hyperspectral retinal image
Hyperspectral image of both eyes
Mydriacyl Ophthalmic Product
Mydriatic drops before retinoscopy
Interventions
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Hyperspectral retinal image
Hyperspectral image of both eyes
Mydriacyl Ophthalmic Product
Mydriatic drops before retinoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
Yes
Sponsors
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Sundets Ögonläkare
UNKNOWN
Mantis Photonics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Madeleine Selvander, MD
Role: PRINCIPAL_INVESTIGATOR
Sundets Ögonläkare
Locations
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Sundets Ögonläkare
Helsingborg, Skåne County, Sweden
Countries
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References
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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.
Hardarson SH, Stefansson 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.
Johnson WR, Wilson DW, Fink W, Humayun M, Bearman G. Snapshot hyperspectral imaging in ophthalmology. J Biomed Opt. 2007 Jan-Feb;12(1):014036. doi: 10.1117/1.2434950.
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.
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.
Meinke M, Muller 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. doi: 10.1364/ao.46.001742.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MANTIS_2022_08_Oxygenation_S
Identifier Type: -
Identifier Source: org_study_id
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