Status:
COMPLETED
Validation of Bulbicam for DR- and AMD-patients
Lead Sponsor:
Meddoc
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Diabetic Retinopathy
Age-Related Macular Degeneration
Eligibility:
All Genders
18-80 years
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 h...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05441072
Start Date
December 19 2022
End Date
June 15 2023
Last Update
May 22 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0450