Alzheimer Disease, Early OnsetNCT05604183
Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease
A study testing non-invasive hyperspectral retinoscopy, blood sample and Test of cognitive ability on tablet computer with CoGNIT software in people with Alzheimer Disease, Early Onset and Cognitive Impairment, run by Mantis Photonics AB at 2 sites in Sweden.
Trial summary
Two devices will be tested in this research: 1. Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation). 2. Blekinge CoGNIT cognitive ability test (i.e., an assessment). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Early Onset, Cognitive Impairment, Cognitive Decline
- What is being tested?
- non-invasive hyperspectral retinoscopy, blood sample and Test of cognitive ability on tablet computer with CoGNIT software
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 2022to 29 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject age over 18 years old
- The subject has undergone a lumbar puncture an cerebrospinal fluid analysis as part of the standard care.
- The subject has at least one healthy eye.
- The subject is applicable for taking a blood sample for the blood analysis test.
- The informed consent is provided, explained and understood by the person. The person has consented to the informed consent.
Who cannot join
- There are contra-indications for lumbar puncture (eg: brain tumor with suspicion of raised intracranial pressure, coagulopathies or ongoing anticoagulant medications) will be excluded from the study.
- When the subject suffers from excessive visual or auditive impairment, the he/she will be excluded from the CoGNIT track.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Blekinge Tekniska Högskola
Karlskrona, Blekine Län, 37141
Anders Behrens, MD, Phd, +460702034496, anders.behrens@regionblekinge.se
Blekinge Hospital
Karlskrona, Blekinge County, 37141
Anders Behrens, MD, PhD, +460702034496, anders.behrens@regionblekinge.se
About this study
Two devices will be tested in this research:
- Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation).
- Blekinge CoGNIT cognitive ability test (i.e., an assessment).
Read the detailed description
Worldwide, millions of people are affected by neurodegenerative diseases (e.g., Alzheimer's disease, dementia). Those diseases are having a tremendous socio-economic impact on our society. The cost associated with treating and caring for those diseases is enormous. Overwhelming evidence indicates how selective lifestyle changes (e.g., reducing exposure to known risk factors) can sometimes significantly decrease the probability of developing the disease or delay its onset. However, the diseases must be diagnosed early for them to be effective. There is a lack of accessible, inexpensive, and non-invasive practices that would allow for an early diagnosis of different diseases, even at the primary physician's office. Mantis Photonics and Blekinge Tekniska Högskola (Institustionen för Hälsa) aim to fill this urgent unmet medical need.
Strong indications of the possibility of classifying Alzheimer's status based on hyperspectral scans of the retina have been published by different researchers. These results were obtained based on images taken with hyperspectral cameras with a different working principle than the Mantis Photonics camera. The working principle of the Mantis Photonics camera allows making a hyperspectral retinoscopy with the same spectral range and comparable or better spectral resolution with a machine that is more modular and lower in cost. There is thus reason to hypothesize retinal scans taken with the Mantis Photonics camera can be used for the same classification task.
Previous studies on the automated tablet computer cognitive test CoGNIT have established validity, reliability and sensitivity for testing patients with Normal Pressure Hydrocephalus (NPH) . Recently feasibility of testing in Mild Cognitive Impairment (MCI) was affirmed (Behrens, Berglund, \& Anderberg, CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study, 2022). In NPH patients, CoGNIT was more sensitive to cognitive impairment at baseline and cognitive improvement after shunt surgery than the Mini-Mental State Examination (MMSE).
Blood tests for amyloid-β and other biomarkers related to Alzheimer's disease are being investigated for clinical practice, but the technique is not accepted as a standard test. Research has shown that renal function influences amyloid-β clearance from the body. Also, analytical errors influence test results. Therefore, one can question the influence of normal repeatability of the blood test result.
The aim of this investigation is the evaluation, (further) development and comparison of non-invasive techniques for the evaluation of patients suffering mild cognitive impairment, in particular, the Mantis Photonics hyperspectral camera with classification machine learning model in combination with the CoGNIT test of Dr Behrens (Blekinge Tekniska Högskola). These techniques will be compared to the result of cerebrospinal fluid analysis (CSF), the reference biological diagnostic technique for Alzheimer's disease.
- Being tested
- non-invasive hyperspectral retinoscopy, blood sample, Test of cognitive ability on tablet computer with CoGNIT software
- Keywords
- Retinoscopy, Non-invasive, Accessible healthcare
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive hyperspectral retinoscopyProcedure or surgery
Also called eye-scan, fundus image (of the eye)
The Principal Investigator or a trained medical nurse (under the supervision of the principal investigator) will take an image of the retina of the patient with the Mantis Photonics hyperspectral retinoscopy camera.
blood sampleProcedure or surgery
Also called draw blood
The Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will draw a small blood sample according to the standard medical procedures for drawing blood samples.
Test of cognitive ability on tablet computer with CoGNIT softwareDiagnostic test
Also called CoGNIT test, Cognitive test, Mental ability test
The Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will give the patient to perform the digital cognitive test on a commercial tablet computer. The Principal Investigator or the medical nurse will be available for the patient to ask questions while the test is ongoing.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Experimental | On all subjects included in the study (see inclusion / exclusion criteria and informed consent) both procedures will be performed.
The result of these procedures (retinal scan, result from cognitive test and blood sample) will be used to build diagnostic classification models. Receives: Procedure: non-invasive hyperspectral retinoscopy; Procedure: blood sample; Diagnostic Test: Test of cognitive ability on tablet computer with CoGNIT software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy (Statistical metric) retinal image classification model
Performance metric of the retinal image classification model: model accuracy [percent]
Measured: within 2 months after last patient procedure
Area under the Curve (statistical metrics) retinal image classification model
Performance metric of the retinal image classification model: Area under the Curve (AuC) [0 < AuC < 1]
Measured: within 2 months after last patient procedure
Sensitivity (Statistical metric) retinal image classification model
Performance metrics of the retinal image classification model: Sensitivity [percent]
Measured: within 2 months after last patient procedure
CoGNIT test diagnostic accuracy
Accuracy [percent] of diagnosis based on the CoGNIT test data
Measured: within 2 months after last patient procedure
Secondary outcomes (4)
Accuracy: Metrics combination model
A combination model of both non-invasive techniques will be evaluated based on the same metrics as the single-technique model (see primary objectives) and evaluated based on the comparison of said metrics: accuracy [percent] for the optimal choice of threshold.
Measured: within 3 months after last patient procedure
Area Under the Curve: Metrics combination model
A combination model of both non-invasive techniques will be evaluated based on the same metrics as the single-technique model (see primary objectives) and evaluated based on the comparison of said metrics: Area Under the Curve [0<AUC<1] for the optimal choice of threshold.
Measured: within 3 months after last patient procedure
Sensitivity: Metrics combination model
A combination model of both non-invasive techniques will be evaluated based on the same metrics as the single-technique model (see primary objectives) and evaluated based on the comparison of said metrics: sensitivity [percent] for the optimal choice of threshold.
Measured: within 3 months after last patient procedure
Non invasive test variability compared to reference
The variability [relative and normalized: percent] between the first and the second hyperspectral retinoscopy result will be compared to the variability between the blood analysis at the first and the second appointment [relative and normalized: percent]. The blood test variability will be used as a reference in this study.
Measured: within 3 months after last patient procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study startNov 2022 (estimated)
- Primary completion29 Dec 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantis Photonics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blekinge Institute of Technology, Blekinge County Council Hospital
- Responsible party
- Sponsor
- Investigators
- Anders Behrens, MD, PhD, Principal investigator, Blekinge Tekniska Högskola
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604183
- Sponsor's protocol ID
- MANTIS_2022_08_CrossSect_B
- Other IDs
- CIV-22-06-039726
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 3 Nov 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
Behrens A, Berglund JS, Anderberg P. CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study. JMIR Form Res. 2022 Mar 11;6(3):e23589. doi: 10.2196/23589.
PubMed 35275064Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.
PubMed 25279138Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.
PubMed 30738407Budelier MM, Bateman RJ. Biomarkers of Alzheimer Disease. J Appl Lab Med. 2020 Jan 1;5(1):194-208. doi: 10.1373/jalm.2019.030080.
PubMed 31843944Hadoux X, Hui F, Lim JKH, Masters CL, Pebay A, Chevalier S, Ha J, Loi S, Fowler CJ, Rowe C, Villemagne VL, Taylor EN, Fluke C, Soucy JP, Lesage F, Sylvestre JP, Rosa-Neto P, Mathotaarachchi S, Gauthier S, Nasreddine ZS, Arbour JD, Rheaume MA, Beaulieu S, Dirani M, Nguyen CTO, Bui BV, Williamson R, Crowston JG, van Wijngaarden P. Non-invasive in vivo hyperspectral imaging of the retina for potential biomarker use in Alzheimer's disease. Nat Commun. 2019 Sep 17;10(1):4227. doi: 10.1038/s41467-019-12242-1.
PubMed 31530809Rasmussen J, Langerman H. Alzheimer's Disease - Why We Need Early Diagnosis. Degener Neurol Neuromuscul Dis. 2019 Dec 24;9:123-130. doi: 10.2147/DNND.S228939. eCollection 2019.
PubMed 31920420Teunissen CE, Verberk IMW, Thijssen EH, Vermunt L, Hansson O, Zetterberg H, van der Flier WM, Mielke MM, Del Campo M. Blood-based biomarkers for Alzheimer's disease: towards clinical implementation. Lancet Neurol. 2022 Jan;21(1):66-77. doi: 10.1016/S1474-4422(21)00361-6. Epub 2021 Nov 24.
PubMed 34838239Dallora AL, Alexander J, Palesetti PP, Guenot D, Selvander M, Berglund JS, Behrens A. Hyperspectral retinal imaging to detect Alzheimer's disease in a memory clinic setting. Alzheimers Res Ther. 2025 Oct 28;17(1):232. doi: 10.1186/s13195-025-01887-4.
PubMed 41153055
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05604183
- Acronym / sponsor ID
- MANTIS_2022_08_CrossSect_B
- Keywords
- Retinoscopy, Non-invasive, Accessible healthcare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mantis Photonics ABIndustry (pharma, biotech, devices)
- Collaborators
- Blekinge Institute of Technology, Blekinge County Council Hospital
- Study start
- Nov 2022 (estimated)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two devices will be tested in this research:
- Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation).
- Blekinge CoGNIT cognitive ability test (i.e., an assessment).
Detailed description
Worldwide, millions of people are affected by neurodegenerative diseases (e.g., Alzheimer's disease, dementia). Those diseases are having a tremendous socio-economic impact on our society. The cost associated with treating and caring for those diseases is enormous. Overwhelming evidence indicates how selective lifestyle changes (e.g., reducing exposure to known risk factors) can sometimes significantly decrease the probability of developing the disease or delay its onset. However, the diseases must be diagnosed early for them to be effective. There is a lack of accessible, inexpensive, and non-invasive practices that would allow for an early diagnosis of different diseases, even at the primary physician's office. Mantis Photonics and Blekinge Tekniska Högskola (Institustionen för Hälsa) aim to fill this urgent unmet medical need.
Strong indications of the possibility of classifying Alzheimer's status based on hyperspectral scans of the retina have been published by different researchers. These results were obtained based on images taken with hyperspectral cameras with a different working principle than the Mantis Photonics camera. The working principle of the Mantis Photonics camera allows making a hyperspectral retinoscopy with the same spectral range and comparable or better spectral resolution with a machine that is more modular and lower in cost. There is thus reason to hypothesize retinal scans taken with the Mantis Photonics camera can be used for the same classification task.
Previous studies on the automated tablet computer cognitive test CoGNIT have established validity, reliability and sensitivity for testing patients with Normal Pressure Hydrocephalus (NPH) . Recently feasibility of testing in Mild Cognitive Impairment (MCI) was affirmed (Behrens, Berglund, \& Anderberg, CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study, 2022). In NPH patients, CoGNIT was more sensitive to cognitive impairment at baseline and cognitive improvement after shunt surgery than the Mini-Mental State Examination (MMSE).
Blood tests for amyloid-β and other biomarkers related to Alzheimer's disease are being investigated for clinical practice, but the technique is not accepted as a standard test. Research has shown that renal function influences amyloid-β clearance from the body. Also, analytical errors influence test results. Therefore, one can question the influence of normal repeatability of the blood test result.
The aim of this investigation is the evaluation, (further) development and comparison of non-invasive techniques for the evaluation of patients suffering mild cognitive impairment, in particular, the Mantis Photonics hyperspectral camera with classification machine learning model in combination with the CoGNIT test of Dr Behrens (Blekinge Tekniska Högskola). These techniques will be compared to the result of cerebrospinal fluid analysis (CSF), the reference biological diagnostic technique for Alzheimer's disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Experimental | Procedure: non-invasive hyperspectral retinoscopy, Procedure: blood sample, Diagnostic Test: Test of cognitive ability on tablet computer with CoGNIT softwareOn all subjects included in the study (see inclusion / exclusion criteria and informed consent) both procedures will be performed. The result of these procedures (retinal scan, result from cognitive test and blood sample) will be used to build diagnostic classification models. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- subject age over 18 years old
- The subject has undergone a lumbar puncture an cerebrospinal fluid analysis as part of the standard care.
- The subject has at least one healthy eye.
- The subject is applicable for taking a blood sample for the blood analysis test.
- The informed consent is provided, explained and understood by the person. The person has consented to the informed consent.
Key exclusion criteria (2 listed)
- There are contra-indications for lumbar puncture (eg: brain tumor with suspicion of raised intracranial pressure, coagulopathies or ongoing anticoagulant medications) will be excluded from the study.
- When the subject suffers from excessive visual or auditive impairment, the he/she will be excluded from the CoGNIT track.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive hyperspectral retinoscopyAlso: eye-scan, fundus image (of the eye)The Principal Investigator or a trained medical nurse (under the supervision of the principal investigator) will take an image of the retina of the patient with the Mantis Photonics hyperspectral retinoscopy camera. | Procedure or surgery | Subjects |
| blood sampleAlso: draw bloodThe Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will draw a small blood sample according to the standard medical procedures for drawing blood samples. | Procedure or surgery | Subjects |
| Test of cognitive ability on tablet computer with CoGNIT softwareAlso: CoGNIT test, Cognitive test, Mental ability testThe Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will give the patient to perform the digital cognitive test on a commercial tablet computer. The Principal Investigator or the medical nurse will be available for the patient to ask questions while the test is ongoing. | Diagnostic test | Subjects |
Primary outcome
Accuracy (Statistical metric) retinal image classification model
Time frame: within 2 months after last patient procedure
Performance metric of the retinal image classification model: model accuracy [percent]
Area under the Curve (statistical metrics) retinal image classification model
Time frame: within 2 months after last patient procedure
Performance metric of the retinal image classification model: Area under the Curve (AuC) [0 < AuC < 1]
Sensitivity (Statistical metric) retinal image classification model
Time frame: within 2 months after last patient procedure
Performance metrics of the retinal image classification model: Sensitivity [percent]
CoGNIT test diagnostic accuracy
Time frame: within 2 months after last patient procedure
Accuracy [percent] of diagnosis based on the CoGNIT test data
4 secondary outcomes
Accuracy: Metrics combination model
Time frame: within 3 months after last patient procedure
Area Under the Curve: Metrics combination model
Time frame: within 3 months after last patient procedure
Sensitivity: Metrics combination model
Time frame: within 3 months after last patient procedure
Non invasive test variability compared to reference
Time frame: within 3 months after last patient procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 35275064Behrens A, Berglund JS, Anderberg P. CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study. JMIR Form Res. 2022 Mar 11;6(3):e23589. doi: 10.2196/23589.
- Background: PubMed 25279138Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.
- Background: PubMed 30738407Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.
- Background: PubMed 31843944Budelier MM, Bateman RJ. Biomarkers of Alzheimer Disease. J Appl Lab Med. 2020 Jan 1;5(1):194-208. doi: 10.1373/jalm.2019.030080.
- Background: PubMed 31530809Hadoux X, Hui F, Lim JKH, Masters CL, Pebay A, Chevalier S, Ha J, Loi S, Fowler CJ, Rowe C, Villemagne VL, Taylor EN, Fluke C, Soucy JP, Lesage F, Sylvestre JP, Rosa-Neto P, Mathotaarachchi S, Gauthier S, Nasreddine ZS, Arbour JD, Rheaume MA, Beaulieu S, Dirani M, Nguyen CTO, Bui BV, Williamson R, Crowston JG, van Wijngaarden P. Non-invasive in vivo hyperspectral imaging of the retina for potential biomarker use in Alzheimer's disease. Nat Commun. 2019 Sep 17;10(1):4227. doi: 10.1038/s41467-019-12242-1.
- Background: PubMed 31920420Rasmussen J, Langerman H. Alzheimer's Disease - Why We Need Early Diagnosis. Degener Neurol Neuromuscul Dis. 2019 Dec 24;9:123-130. doi: 10.2147/DNND.S228939. eCollection 2019.
- Background: PubMed 34838239Teunissen CE, Verberk IMW, Thijssen EH, Vermunt L, Hansson O, Zetterberg H, van der Flier WM, Mielke MM, Del Campo M. Blood-based biomarkers for Alzheimer's disease: towards clinical implementation. Lancet Neurol. 2022 Jan;21(1):66-77. doi: 10.1016/S1474-4422(21)00361-6. Epub 2021 Nov 24.
- Derived from this study: PubMed 41153055Dallora AL, Alexander J, Palesetti PP, Guenot D, Selvander M, Berglund JS, Behrens A. Hyperspectral retinal imaging to detect Alzheimer's disease in a memory clinic setting. Alzheimers Res Ther. 2025 Oct 28;17(1):232. doi: 10.1186/s13195-025-01887-4.
- World Alzheimer Report 2022 - Alzheimer's disease internationalLink provided by the sponsor.
- Individual participant dataSharing planned: No. No Individual Participant Data (IPD) sharing to third parties. Data of individual participants will be used for this study only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Behrens, MD, PhD principal investigator
Blekinge Tekniska Högskola
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive hyperspectral retinoscopy, blood sample and Test of cognitive ability on tablet computer with CoGNIT software in people with Alzheimer Disease, Early Onset and Cognitive Impairment, run by Mantis Photonics AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Anders Behrens, MD, PhD (+460702034496, anders.behrens@regionblekinge.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (Statistical metric) retinal image classification model (time frame: within 2 months after last patient procedure). The study lists 4 primary outcomes in all. 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 NCT05604183, 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 3 Nov 2022.