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Recruiting NCT05680571

Validation of Bulbicam for Parkinson- and Ataxia-patients

Conditions: Parkinson Disease, Ataxia

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Enrollment: 64
Sponsor: Meddoc

Location: Norway

Summary

Aim is to investigate repeatability and stability of four Neurological-related Bulbicam tests in patients suffering Parkinson (PD),Ataxia (AT) and matched healthy control (HC).Study population The study consists of the patients suffering from PD or AT and HV of both genders above 18 years of age without any eye- or neurological disorder.Bulbicam will be used in the study and five tests will be performedThe study will be performed as a controlled, open and non-randomized, stratified observational single center. The stratification factors will be pathology (PD&AT) and internal classifications. ed.The main variables will be the variables recorded at the four Bulbicam tests and the standard neuro-ophthalmological variables included for PD and ATParticipants, 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. During the first day of the study, the included patients will undergo a neuro-ophthalmological examination by a neurologist. Additionally, Bulbicam examination will be performed twice with a rest period of one hour between each registration.The healthy controls will only undergo a standard examination and twice BulbiCam examination. The controls will only participate one day. The patients will participate two more days with two Bulbicam examinations per day.Sample size:Sixteen PD-patients ,16 AT-patients and 32 HCs will be included in the study.

Eligibility Criteria

Inclusion Criteria:Patients diagnosed with either PD or AT of both gender; at least 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 ; 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 Criteria:Other visual disturbances and blindnessPosterior Chamber Intraocular Lens (PCIOL)Physical or psychiatric disease, which may disturb the measuring procedureParesis or paralysis of any oculomotor musclePatients whose visual acuity is less than 0.1 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 haemorrhages or deformed pupilsPatients whose pupils are not able to respond normally to dilation or contraction due to damaged nerves, mechanical damage of the pupil etc.With known alcoholic and drug dependencyNot able to understand information.Not willing to give written consent to participate in the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05680571). StuddyBuddy aggregates publicly available trial information.