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Glaucoma EyeNCT05566626

Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera

A study testing Hyperspectral retinal image and Mydriacyl Ophthalmic Product in people with Glaucoma Eye and Macular Degeneration, run by Mantis Photonics AB at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Hyperspectral retinal image and Mydriacyl Ophthalmic Product
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSweden
Study dates
Oct 2022to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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:
  3. 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sundets Ögonläkare

    Helsingborg, Skåne County, 252 21

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Hyperspectral retinal image, Mydriacyl Ophthalmic Product
Keywords
hyperspectral, retinoscopy, oxygenation, non-invasive
Medical subject headings
Macular Degeneration, Retinal Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperspectral retinal imageDevice

    Also called hyperspectral retinoscopy

    Hyperspectral image of both eyes

  • Mydriacyl Ophthalmic ProductDrug

    Mydriatic drops before retinoscopy

Study groups in NCT05566626
Study groupRoleWhat they receive
Camera test groupExperimentalThe Principal Investigator will take a hyperspectral image of all subjects, both healthy volunteers and patients.
Receives: Device: Hyperspectral retinal image; Drug: Mydriacyl Ophthalmic Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During the procedure (retinoscopy with hyperspectral camera).

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study startOct 2022 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Alle participants, both healthy subjects and patients, receive the same intervention: hyperspectral image with Mantis Photonics camera
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566626
Sponsor's protocol ID
MANTIS_2022_08_Oxygenation_S
Status last verified
Oct 2022
First submitted
22 Sep 2022
Last updated
21 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No Individual Participant Data (IPD) sharing to third parties. Data of individual participants will be used for this study only.

Publications

  • 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.

    PubMed 21952522

  • 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.

    PubMed 33979414

  • 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.

    PubMed 17343511

  • 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.

    PubMed 32949554

  • 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.

    PubMed 24441941

  • 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.

    PubMed 17356617

  • 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.

    PubMed 21440663

  • 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.

    PubMed 29679616

Questions about this trial

What is this clinical trial studying?

A study testing Hyperspectral retinal image and Mydriacyl Ophthalmic Product in people with Glaucoma Eye and Macular Degeneration, run by Mantis Photonics AB at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance evaluation - Retinal Oxygenation (time frame: During the procedure (retinoscopy with hyperspectral camera).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566626, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.

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