Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera

NCT05566626 | Unknown DMC

• 1 other identifier: MANTIS_2022_08_Oxygenation_S
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma Eye; Macular Degeneration; Macula Abnormality; Retinal Detachment

Keywords

hyperspectral; retinoscopy; oxygenation; non-invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Retinal examination exploration - detection of macular degeneration

  After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.

Other Outcomes (2)

• Adverse effect

  Immediately after the retinoscopy procedure.

• Serious adverse effect

  Immediately after the retinoscopy procedure.

Study Arms (1)

Camera test group

EXPERIMENTAL

The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.

Device: Hyperspectral retinal image; Drug: Mydriacyl Ophthalmic Product

Interventions

Hyperspectral retinal image DEVICE

Hyperspectral image of both eyes

Also known as: hyperspectral retinoscopy

Camera test group

Mydriacyl Ophthalmic Product DRUG

Mydriatic drops before retinoscopy

Camera test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mantis Photonics AB: lead
• Sundets Ögonläkare: collaborator

Study Sites (1)

Sundets Ögonläkare

Helsingborg, Skåne County, 252 21, Sweden

Location

Related 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.

  PMID: 21952522 BACKGROUND

• 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.

  PMID: 33979414 BACKGROUND

• 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.

  PMID: 17343511 BACKGROUND

• 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.

  PMID: 32949554 BACKGROUND

• 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.

  PMID: 24441941 BACKGROUND

• 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.

  PMID: 17356617 BACKGROUND

• 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.

  PMID: 21440663 BACKGROUND

• 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.

  PMID: 29679616 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Madeleine Selvander, MD

  Sundets Ögonläkare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Alle participants, both healthy subjects and patients, receive the same intervention: hyperspectral image with Mantis Photonics camera

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)