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- 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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patients | Patients suffering from diabetes without retinopathy of both genders with various durations of disease |
| |
| Age-matched healthy controls | Age-matched healthy controls without any eye diseases except for mild catarakt. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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: 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 1.Acolapt | logMAR | 0 hours |
| 2.Acolapt | logMAR | 2 hours |
| 3. Acolapt | logMAR | 3 hours |
| 4. Acolapt | logMAR | 4 hours |
| 5. Acolapt | logMAR | 5 hours |
| 6. Acolapt | logMAR | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 7.Contrast sensitivity | Pelli-Robson score | 0 hours |
| 8.Contrast sensitivity | Pelli-Robson score | 2 hours |
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Inclusion Criteria:
but have a health situation in accordance with expectations related to the age.
Exclusion Criteria:
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The study population consists of Diabetic patients without retinopathy and healthy controls fulfilling the inclusion criteria and avoiding the exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Goran Petrovski, PhD | Oslo University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0450 | Norway |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 9. Contrast sensitivity | Pelli-Robson score | 3 hours |
| 10. Contrast sensitivity | Pelli-Robson score | 4 hours |
| 11. Contrast sensitivity | Pelli-Robson score | 5 hours |
| 12. Contrast sensitivity | Pelli-Robson score | 6 hours |