Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05449041 |
Other study ID # |
V2_OTH/GLA;CAT-I/2022 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 10, 2023 |
Est. completion date |
May 31, 2023 |
Study information
Verified date |
May 2024 |
Source |
Meddoc |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim is to investigate repeatability and stability of the six OTH-related Bulbicam tests
in patients suffering from Glaucoma (GLA), b) Cataract (CAT) and matched healthy controls
(HC).
The study population consists of the three subpopulations: 1) Patients suffering from GLA; 2)
Patients suffering from CAT and 3) Gender- and age-matched HC without any eye diseases.
Bulbicam will be used in the study including six tests and the standard method will be used
initially for measurements of "Visual Field" and "Pupil"
The study will be performed as a controlled, open, and non-randomized, stratified
observational single center study. The stratification factors will be pathology and the
degree of disease. Within each of the four strata, healthy matched controls related to gender
and age (1:1) will be included.
The main variables will be the variables recorded at the six Bulbicam and the supporting
variables will be recorded by the Standard (ST) investigation. The central variables related
to Glaucoma will be the GAT and iCare pressure, "Seen /unseen "," Time until the given point
is recorded as seen", "the light in decibel when the point is seen", X- and Y-coordinates and
"Pupil diameter in mm".
The central variables related to cataract will be "Pupil diameter", "OCT RNFL ", "Seen
/unseen "," Time until the given point is recorded as seen", "the light in decibel when the
point is seen" and the X- and Y-coordinates.
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.
Sixteen GLA-patients and 16 CAT-patients equally divided into two substrata will be recruited
from the two participating hospitals. For each included patient, one gender- and age-matched
HC will be recruited. In total 16 GLA-patients with 16 HC and 16 CAT-patients with 16 HC will
be included in the study.
Description:
Aim
- To investigate repeatability and stability of the six OTH-related Bulbicam tests in
patients suffering from a) Glaucoma (GLA), b) Cataract (CAT) and matched healthy
controls (HC).
- To compare Bulbicam and the standard method on measurements of Visual field and Pupil
- To contribute to establishment of normal range for GLA and CAT patients with different
degrees in the disease development related to the Bulbicam tests.
- To contribute to establishment of normal range for a normal population without
eye-disease related to the Bulbicam tests. Study population consists of the following
three study populations: 1) Patients suffering from GLA of both genders above 18 years
of age with different disease degree; 2) Patients suffering from CAT of both genders
above 18 years of age with different disease degree; 3) Gender- and age-matched HC
without any eye diseases.
Trial equipment: Bulbicam will be used in the study and the following six tests will be
performed at each investigation: "Visual Field", "Ptosis", Dynamic Acuity", "Dynamic Contrast
", "Dark Adaption" and "Pupil". The standard method will be used initially for measurements
of "Visual Field" and "Pupil"
Design:
The study will be performed as a controlled, open, and non-randomized, stratified
observational single center study. The stratification factors will be pathology (GLA&CAT) and
the degree of disease. Within each of the four strata, healthy matched controls related to
gender and age (1:1) will be included. The degree of GLA is defined as follows:
1. Mild glaucoma
2. Moderate glaucoma
3. Severe glaucoma
The degree of CAT is defined as follows:
1. Cataract Nuclear Sclerosis - Grade 1
2. Cataract Nuclear Sclerosis - Grade 2
Higher grade cataracts are difficult to have occurred in Norway and thus excluded from this
study.
For each included patient, a gender- and age-matched HV will be included. All included
participants will perform Bulbicam eye-investigation twice at three flowing days with a rest
period of at least one hour. Each investigation includes same six Bulbicam tests. The
Standard method will only be performed once as the first investigation at day 1 for
measurements of "Visual Field" and "Pupil".
Main variables will be the variables recorded at the six Bulbicam tests. Supporting Variables
will be recorded by the Standard (ST) investigation for Glaucoma and Cataract.
The central variables related to Glaucoma will be the GAT and iCare pressure, "Seen /unseen
"," Time until the given point is recorded as seen", "the light in decibel when the point is
seen", X- and Y-coordinates and "Pupil diameter in mm". The central variables related to
cataract will be "Pupil diameter", "OCT RNFL ", "Seen /unseen "," Time until the given point
is recorded as seen", "the light in decibel when the point is seen" and the X- and
Y-coordinates.
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.
Sample size:
Sixteen GLA-patients and 16 CAT-patients equally divided into two substrata will be recruited
from the two participating hospitals. For each included patient, one gender- and age-matched
HC will be recruited. In total 16 GLA-patients with 16 HC and 16 CAT-patients with 16 HC will
be included in the study. All together the study will include 64 participants.