Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera

October 20, 2022 updated by: Mantis Photonics AB

A Single Centre, Controlled, Investigation to Evaluate the Performance of the Hyperspectral Camera for Retinal Non-invasive Examination Through the Observation of Retinal Oxygenation

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne Län
      • Helsingborg, Skåne Län, Sweden, 252 21
        • Sundets Ögonläkare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Camera test group
The Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
Device: Hyperspectral retinal image
Hyperspectral image of both eyes
Other Names:
  • hyperspectral retinoscopy
Drug: Mydriacyl Ophthalmic Product
Mydriatic drops before retinoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance evaluation - Retinal Oxygenation
Time Frame: During the procedure (retinoscopy with hyperspectral camera).

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal examination exploration - detection of macular degeneration
Time Frame: After the procedure (retinoscopy with hyperspectral camera). Manual evaluation in the week after the procedure.

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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effect
Time Frame: Immediately after the retinoscopy procedure.

Measurement:

Percentage of patients who report adverse effects such as transient 'imprint' of the flash or other adverse effects.
Immediately after the retinoscopy procedure.
Serious adverse effect
Time Frame: Immediately after the retinoscopy procedure.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mantis Photonics AB

Collaborators

Sundets Ögonläkare

Investigators

  • Principal Investigator: Madeleine Selvander, MD, Sundets Ögonläkare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANTIS_2022_08_Oxygenation_S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No Individual Participant Data (IPD) sharing to third parties. Data of individual participants will be used for this study only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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