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Validation of Bulbicam Used on Patient Suffering From Diabetes Without Retinopathy

NCT06973694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Bulbicam

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.

Sponsors & Collaborators

  • Meddoc

    lead OTHER

Principal Investigators

  • Goran Petrovski, PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2024-08-12
Completion
2025-04-16
FDA Device
Yes

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06973694 on ClinicalTrials.gov