DiabetesNCT06973694
Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy
An observational study of Diabetes, run by Meddoc at 1 site in Norway.
Trial summary
The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Bulbicam
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- 3 Jun 2024to 16 Apr 2025
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of Diabetic patients without retinopathy and healthy controls fulfilling the inclusion criteria and avoiding the exclusion criteria
Who may be able to join
- Consists of patients diagnosed with Diabetes without retinopathy of both gender; passed the age of 18 years without any other eye disease; suffering from other know serious disease.
- but have a health situation in accordance with expectations related to the age.
- Gender- and age-matched controls to patients in, passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.
Who cannot join
- Other visual disturbances and blindness
- Posterior Chamber Intra Ocular Lens (PCIOL)
- Physical or psychiatric disease, which may disturb the measuring procedure
- Patients who are not able to perform eye movements, so no full paresis of any ocular muscles.
- Patients whose visual acuity is less more than 1 logMAR in any eye, as these will not be able to focus on the test stimuli.
- Patients whose visible part of the eye is abnormal, such as subconjunctival hemorrhages or deformed pupils.
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- Patients whose pupils are not able to respond normally to dilation or contraction due to damaged nerves, mechanical damage of the pupil etc.
- Participating in another clinical trial with pharmaceuticals the last six weeks before start of this trial treatment.
- With known alcoholic and drug dependency
- Not able to understand information.
- Not willing to give written consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
- The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt.
Six bulbicam tests together with the standard method will be used in the study.
Read more
- The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The standard method will only be performed once as the first investigation at day 1.
- The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
- Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values.
The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.
- Sixteen diabetes-patients with eaual many age-matched HC will be included.
Read the detailed description
- The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt.
- The six bulbicam tests "Visual acuity", "Contrast sensitivity", "Light adaptation latency with fixed frequency and variable contrast", "Light adaptation latency with variable frequency and fixed contrast" and "two pupil tests will be used. The Standard Method will be used initially for measurements of "iCare", "Visual acuity", "Refraction", "Contrast", "OCT" and "Fundus photography".
- The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The standard method will only be performed once as the first investigation at day 1
- The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
- Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values.
The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.
- Sixteen diabetes-patients with eaual many age-matched HC will be included.
- Conditions
- Diabetes
- Being tested
- Bulbicam
- Keywords
- Bulbicam, Reliability, Stability, Validity
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulbicamDevice
The multi-test device, BulbiCam (BCAM), is a combined eye tracking; pupil metric; video graphic dual device which include the following 10 tests under development and ready for validation:
26 grids glaucoma screening perimetry 64 grids full perimetry (NeuroField64) Pupil and Relative Afferent Pupil Defect (RAPD) assessment Semi-automatic ptosis (droopy eyelid) grading Video-based nystagmus test Dynamic acuity and contrast sensitivity test Dark adaptation test Smooth pursuit eye movements Saccade movements Eye fixation stability BCAM is connected to the BulbiHub software where measured data is stored and presented in numbers, diagrams, and graphs.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Patients suffering from diabetes without retinopathy of both genders with various durations of disease Receives: Device: Bulbicam | |
| Age-matched healthy controls | Age-matched healthy controls without any eye diseases except for mild catarakt. Receives: Device: Bulbicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Acolapt
logMAR
Measured: 0 hours
2.Acolapt
logMAR
Measured: 2 hours
3. Acolapt
logMAR
Measured: 3 hours
4. Acolapt
logMAR
Measured: 4 hours
5. Acolapt
logMAR
Measured: 5 hours
6. Acolapt
logMAR
Measured: 6 hours
Secondary outcomes (6)
7.Contrast sensitivity
Pelli-Robson score
Measured: 0 hours
8.Contrast sensitivity
Pelli-Robson score
Measured: 2 hours
9. Contrast sensitivity
Pelli-Robson score
Measured: 3 hours
10. Contrast sensitivity
Pelli-Robson score
Measured: 4 hours
11. Contrast sensitivity
Pelli-Robson score
Measured: 5 hours
12. Contrast sensitivity
Pelli-Robson score
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start3 Jun 2024
- Primary completion12 Aug 2024
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meddoc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Stig Larsen, Meddoc
- Investigators
- Goran Petrovski, PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973694
- Sponsor's protocol ID
- V4-OTH/D-I/2023
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy
- ClinicalTrials.gov ID
- NCT06973694
- Acronym / sponsor ID
- V4-OTH/D-I/2023
- Conditions
- Diabetes
- Keywords
- Bulbicam, Reliability, Stability, Validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- MeddocUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 15 May 2025 (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.
- The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt.
Six bulbicam tests together with the standard method will be used in the study.
- The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The standard method will only be performed once as the first investigation at day 1.
- The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
- Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values.
The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.
- Sixteen diabetes-patients with eaual many age-matched HC will be included.
Detailed description
- The study consists of the following two study populations: 1) Patients suffering from diabetes without retinopathy of both genders with various durations of disease 2) Age-matched healthy control (HC) without any eye diseases except for mild catarakt.
- The six bulbicam tests "Visual acuity", "Contrast sensitivity", "Light adaptation latency with fixed frequency and variable contrast", "Light adaptation latency with variable frequency and fixed contrast" and "two pupil tests will be used. The Standard Method will be used initially for measurements of "iCare", "Visual acuity", "Refraction", "Contrast", "OCT" and "Fundus photography".
- The study will be performed as a controlled, open, and non-randomized observational multicenter study. For each included patient and age-matched HC will be included. All included participants will perform Bulbicam eye-investigation six times within three flowing days with a rest period of at least one hour. Each investigation includes same six Bulbicam tests. The standard method will only be performed once as the first investigation at day 1
- The main variables will be the variables recorded at the four ACOLAPT- and two Pupil Bulbicam tests.
- Participants, who fulfil the inclusion criteria; do not meet any of the exclusion criteria and willing to give informed consent to participate will receive an appointment for starting the study. The Bulbicam examination will be performed twice a day with a rest period of one hour between each registration. This procedure will be repeated the following two days. All demographic data, social factors and history of disease will be recorded at screening. Additionally, the quality of life (QoL) questionnaires EQ-5D-5L developed by EuroQol will be recorded initially as individual baseline values.
The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for measuring and classifying the tolerability and toxicity at the end of each day of investigation.
- Sixteen diabetes-patients with eaual many age-matched HC will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Device: BulbicamPatients suffering from diabetes without retinopathy of both genders with various durations of disease |
| Age-matched healthy controls | – | Device: BulbicamAge-matched healthy controls without any eye diseases except for mild catarakt. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of Diabetic patients without retinopathy and healthy controls fulfilling the inclusion criteria and avoiding the exclusion criteria
Key inclusion criteria (3 listed)
- Consists of patients diagnosed with Diabetes without retinopathy of both gender; passed the age of 18 years without any other eye disease; suffering from other know serious disease.
- but have a health situation in accordance with expectations related to the age.
- Gender- and age-matched controls to patients in, passed the age of 18 years without any eye diseases; not suffering from other know serious disease and have a health situation in accordance with expectations related to the age.
Key exclusion criteria (11 listed)
- Other visual disturbances and blindness
- Posterior Chamber Intra Ocular Lens (PCIOL)
- Physical or psychiatric disease, which may disturb the measuring procedure
- Patients who are not able to perform eye movements, so no full paresis of any ocular muscles.
- Patients whose visual acuity is less more than 1 logMAR in any eye, as these will not be able to focus on the test stimuli.
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 |
|---|---|---|
| BulbicamThe multi-test device, BulbiCam (BCAM), is a combined eye tracking; pupil metric; video graphic dual device which include the following 10 tests under development and ready for validation: 26 grids glaucoma screening perimetry 64 grids full perimetry (NeuroField64) Pupil and Relative Afferent Pupil Defect (RAPD) assessment Semi-automatic ptosis (droopy eyelid) grading Video-based nystagmus test Dynamic acuity and contrast sensitivity test Dark adaptation test Smooth pursuit eye movements Saccade movements Eye fixation stability BCAM is connected to the BulbiHub software where measured data is stored and presented in numbers, diagrams, and graphs. | Device | Age-matched healthy controls, Diabetic patients |
Primary outcome
1.Acolapt
Time frame: 0 hours
logMAR
2.Acolapt
Time frame: 2 hours
logMAR
3. Acolapt
Time frame: 3 hours
logMAR
4. Acolapt
Time frame: 4 hours
logMAR
5. Acolapt
Time frame: 5 hours
logMAR
6. Acolapt
Time frame: 6 hours
logMAR
6 secondary outcomes
7.Contrast sensitivity
Time frame: 0 hours
8.Contrast sensitivity
Time frame: 2 hours
9. Contrast sensitivity
Time frame: 3 hours
10. Contrast sensitivity
Time frame: 4 hours
11. Contrast sensitivity
Time frame: 5 hours
12. Contrast sensitivity
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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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.
Goran Petrovski, PhD study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Meddoc at 1 site in Norway.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 15 May 2025. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1.Acolapt (time frame: 0 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.