Validation of Bulbicam for DR- and AMD-patients

NCT05441072 | Completed DMC FDA Device

• 1 other identifier: V1-OTH /DR; AMD-I/2022
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Retinopathy; Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (12)

• Visual Field

  Saccadic Reaction Time

  0 hours

• Visual Field

  Saccadic Reaction Time

  2 hours

• Visual Field

  Saccadic Reaction Time

  4 hours

• Visual Field

  Saccadic Reaction Time

  24 hours

• Visual Field

  Saccadic Reaction Time

  26 hours

• Visual Field

  Saccadic Reaction Time

  28 hours

• Ptosis

  Margin to reflex distanse

  0 hours

• Ptosis

  Margin to reflex distanse

  2 hours

• Ptosis

  Margin to reflex distanse

  4 hours

• Ptosis

  Margin to reflex distanse

  24 hours

• Ptosis

  Margin to reflex distanse

  26 hours

• Ptosis

  Margin to reflex distanse

  28 hours

Study Arms (4)

Diabetic Retinopathy (DR)

Patients suffering from DR of both genders above 18 years of age with different disease degree. Each patient will be measured with BulbiCam device 6 times within three days

Device: BulbiCam

Healthy controls DR

Gender- and age-matched healthy controls without any eye disease to the DR patients

Device: BulbiCam

Age related macular degeneration (AMD)

Patients suffering from AMD of both genders above 18 years of age with different disease degree.

Device: BulbiCam

Healthy controls AMD

Gender- and age-matched healthy controls without any eye disease to the AMD patients

Device: BulbiCam

Interventions

BulbiCam DEVICE

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.

Age related macular degeneration (AMD); Diabetic Retinopathy (DR); Healthy controls AMD; Healthy controls DR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of DR, AMD patients and healthy controls fulfilling the inclusion criteria and avoiding the exclusion criteria

You may qualify if:

• Consists of patients diagnosed with either DR or AMD 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 study population 1 or 2; 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meddoc: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration

Study Officials

• Goran Petrovski, PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 1, 2022
• Study Start: December 19, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 15, 2023
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)