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Validation of Bulbicam for DR- and AMD-patients

NCT05441072 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2024-05-22

No results posted yet for this study

Summary

Aim

* To investigate repeatability and stability of the six OTH-related Bulbicam tests in patients suffering from a) Diabetic retinopathy (DR), b) Age related macular degeneration (AMD) and matched healthy controls (HC).
* To compare Bulbicam and the Standard Method on measurements of Visual Field and Pupil
* To contribute to the establishment of normal range for DR and AMD patients with different degree in the disease development related to the Bulbicam tests.
* To contribute to the establishment of normal range for a normal population without eye-disease related to the Bulbicam tests. Study population The study consists of the following three study populations: 1) Patients suffering from DR of both genders above 18 years of age with different disease degree; 2) Patients suffering from AMD of both genders above 18 years of age with different disease degree; 3) Gender- and age-matched HC without any eye diseases.

Study procedure 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.

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: 1. 26 grids glaucoma screening perimetry 2. 64 grids full perimetry (NeuroField64) 3. Pupil and Relative Afferent Pupil Defect (RAPD) assessment 4. Semi-automatic ptosis (droopy eyelid) grading 5. Video-based nystagmus test 6. Dynamic acuity and contrast sensitivity test 7. Dark adaptation test 8. Smooth pursuit eye movements 9. Saccade movements 10. Eye fixation stability BCAM is connected to the BulbiHub software where measured data is stored and presented in numbers, diagrams, and graphs.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • 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
2022-12-19
Primary Completion
2023-05-01
Completion
2023-06-15
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 NCT05441072 on ClinicalTrials.gov