Clinical trial NCT05680571: Validation of Bulbicam for Parkinson- and Ataxia-patients
Official title: Validation of Bulbicam for Use on Patient Suffering From Parkinson and Ataxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Ataxia
Lead sponsor: Meddoc
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of PD and AT-patients of both gender; past the age of 18 years; without any other eye disease and suffering from other know serious disease, but have a health situation in accordance with expectations related to the age.

Brief 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 performed

The 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 AT

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. 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.

Detailed description: Aim

* To investigate repeatability and stability of four Neurological-related Bulbicam tests in patients suffering from PD, AT and HC.
* To contribute to establishment of normal range for PD and AT patients with different degree in the disease development related to the Bulbicam tests.
* To contribute to establishment of normal range of these Bulbicam tests for a normal population without neurological or ophthalmological disease.

Study population The study consists of the following three study populations: 1) Patients suffering from PD of both genders above 18 years of age; 2) Patients suffering from AT of both genders above 18 years of age; 3) Gender- and age-matched HC without any eye- or neurological disorder.

Trial equipment Bulbicam will be used in the study and the following five tests will be performed at each investigation: "Fixation", "Saccade" "Nystagmus", "Smooth pursuit" and "Pupil".

Design:

The 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. Within each of the two basic strata, healthy matched controls related to gender and age (1:1) will be included. No internal classification will be used for PD, but AT will be stratified in:

1. Patients with Nystagmus
2. Patients without Nystagmus For each included patient, a gender- and age-matched HV will be included.

The main variables will be the variables recorded at the four Bulbicam tests. The standard neuro-ophthalmological variables included for PD and AT are Nystagmus, Smooth pursuit and Saccade Accurate.

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. 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.

All demographic data, social factors and history of disease will be recorded at screening. The general 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.

Sample size:

Sixteen PD-patients and 16 AT-patients, equally divided between the internal pairs of strata, will be recruited from the participating hospital. For each included patient, one gender- and age-matched HC will be recruited. In total of 32 HC, 16 PD and 16 AT patients 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 blindness
* Posterior Chamber Intraocular Lens (PCIOL)
* Physical or psychiatric disease, which may disturb the measuring procedure
* Paresis or paralysis of any oculomotor muscle
* Patients 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 pupils
* Patients 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 dependency
* Not able to understand information.
* Not willing to give written consent to participate in the study.

Primary outcomes:
measure: Nystagmus
timeFrame: 1 hour
measure: Nystagmus
timeFrame: 2 hours
measure: Nystagmus
timeFrame: 24 hours
measure: Nystagmus
timeFrame: 25 hours
measure: Nystagmus
timeFrame: 36 hours
measure: Nystagmus
timeFrame: 37 hours
measure: Fixation
timeFrame: 1 hour
measure: Fixation
timeFrame: 2 hours
measure: Fixation
timeFrame: 24 hours
measure: Fixation
timeFrame: 25 hours
measure: Fixation
timeFrame: 36 hours
measure: Fixation
timeFrame: 37 hours
measure: Smooth pursuit 1
timeFrame: 1 hour
measure: Smooth pursuit 1
timeFrame: 2 hours
measure: Smooth pursuit 1
timeFrame: 24 hours
measure: Smooth pursuit 1
timeFrame: 25 hours
measure: Smooth pursuit 1
timeFrame: 36 hours
measure: Smooth pursuit 1
timeFrame: 37 hours
measure: Saccade
timeFrame: 1 hour
measure: Saccade
timeFrame: 2 hours
measure: Saccade
timeFrame: 24 hours
measure: Saccade
timeFrame: 25 hours
measure: Saccade
timeFrame: 36 hours
measure: Saccade
timeFrame: 37 hours
measure: Pupil
timeFrame: 1 hour
measure: Pupil
timeFrame: 2 hours
measure: Pupil
timeFrame: 24 hours
measure: Pupil
timeFrame: 25 hours
measure: Pupil
timeFrame: 36 hours
measure: Pupil
timeFrame: 37 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Emilia Kerty, PhD
role: PRINCIPAL_INVESTIGATOR
References: