Clinical trial NCT06973694: Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy
Official title: Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Bulbicam
Reliability
Stability
Validity
Lead sponsor: Meddoc
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of Diabetic patients without retinopathy and healthy controls fulfilling the inclusion criteria and avoiding the exclusion criteria

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: 1.Acolapt
timeFrame: 0 hours
measure: 2.Acolapt
timeFrame: 2 hours
measure: 3. Acolapt
timeFrame: 3 hours
measure: 4. Acolapt
timeFrame: 4 hours
measure: 5. Acolapt
timeFrame: 5 hours
measure: 6. Acolapt
timeFrame: 6 hours
Secondary outcomes:
measure: 7.Contrast sensitivity
timeFrame: 0 hours
measure: 8.Contrast sensitivity
timeFrame: 2 hours
measure: 9. Contrast sensitivity
timeFrame: 3 hours
measure: 10. Contrast sensitivity
timeFrame: 4 hours
measure: 11. Contrast sensitivity
timeFrame: 5 hours
measure: 12. Contrast sensitivity
timeFrame: 6 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Goran Petrovski, PhD
role: STUDY_DIRECTOR
References: