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
Verified date | October 2022 |
Source | Mantis Photonics AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sundets Ögonläkare | Helsingborg | Skåne Län |
Lead Sponsor | Collaborator |
---|---|
Mantis Photonics AB | Sundets Ögonläkare |
Sweden,
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
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. |
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