1. Optimize the EMC-test*s potential to predict the SAP-parameter Mean Deviation (MD), based on simulated visual field defects in healthy observers.2. Refine the EMC-test*s potential to predict the SAP-parameter MD in patients.
ID
Source
Brief title
Condition
- Other condition
- Glaucoma and ocular hypertension
Synonym
Health condition
niet- aangeboren hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints of the study are the validity and the test-retest
reliability of the EMC-test:
1. convergent validity: difference (dB) between the predicted MD (EMC) and the
assessed MD (SAP), expressed as delta MD.
2. test-retest reliability: the variability of the predicted MD (dB) between
consecutive measurements in the same person
Secondary outcome
N/A
Background summary
An intact visual field is extremely important for daily functioning. For
instance, it is a prerequisite to be allowed to drive a car, for instance. The
current gold standard to measure the visual field is by means of standard
automated perimetry (SAP). This technique requires prolonged focussed
attention, understanding of the test and multi-tasking. This precondition
excludes valid and reliable use of SAP in very old persons or persons with
cognitive and/or motor impairments, critically limiting the quality of vision
care and rehabilitation services such persons should receive. A breakthrough
for these persons and their care would be a short perimetric screening test
that requires minimal effort and attentional focus. A recently developed
eye-movement-based perimetric screening test (EMC-test), holds great promise
towards this aim. Therefore, we hypothesise that the EMC test overcomes the
limitations of SAP. The Promise study will evaluate this in two patient groups.
However, before it can be incorporated into daily care and services, the EMC*s
capabilities need to be investigated further. In particular, we need to
determine how its outcomes relate exactly to those of SAP. This is the aim of
the present study.
Study objective
1. Optimize the EMC-test*s potential to predict the SAP-parameter Mean
Deviation (MD), based on simulated visual field defects in healthy observers.
2. Refine the EMC-test*s potential to predict the SAP-parameter MD in patients.
Study design
Multiple observational case-control studies.
Study burden and risks
The EMC test itself is very simple to perform, and exists of following a moving
and jumping dot on the screen with one*s eyes for 20 secs at a time while we
track the eyes with a remote eyetracker. In addition, a calibration of the
tracker is required. Total testing takes on average about 10-15 minutes. In
addition, a number of standard ophthalmic tests are performed.
The total test time and location for each group is summarized below.
Total test time and test location per experiment.
Experiment O1-5: Healthy control participants (n=5x20); Total test time Visit:
165 minutes; Location: UMCG, Ophthalmology Outpatient Clinic
Experiment A1: Healthy control participants (n=45); Total test time Visit 1:
120 minutes; Visit 2: 45 minutes; Location: UMCG, Ophthalmology Outpatient
Clinic
Experiment A2 Glaucoma patients (n=45); Total test time Visit 1: 60 minutes;
Visit 2: 15 minutes; Location UMCG, Ophthalmology Outpatient Clinic
Experiment A3 ABI patients with CI, without VFD (n=15); Total test time Visit
1: 105 minutes; Visit 2: 60 minutes; Location: UMCG, Ophthalmology Outpatient
Clinic
Experiment A4 ABI patients without CI with VFD (n=15); Total test time Visit 1:
60 minutes; Visit 2: 15 minutes; Location: UMCG, Ophthalmology Outpatient
Clinic.
Participants will be made aware that they can refuse or end participation in
the study at any time. For all patients and healthy control participants: If
any abnormal screening results are obtained in any of the screenings, they will
be referred to their GP. Detection of signs of an eye condition or cognitive
impairment may come as an unexpected, unpleasant surprise, however, an early
diagnosis will allow treatments to be initiated and therefore enable more
preservation of visual or cognitive functioning.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Participant without vision loss (control participant; experiment O, A1)
-18 years or older.
• Informed written consent
Participant with Glaucoma (experiment A2):
•Diagnosed with glaucoma
•Reliable SAP (based on most recent SAP assessment, information in their
medical file).
•Age 50-70
•No cognitive impairments (MoCa score: score >= 24; TOSSA screening test score
> 5th percentile)
•Informed written consent
Participant with ABI (experiment A3):
•Diagnosed with acquired brain injury
•Cognitive impairment (CI), based on test scores regular care UMCG.
•Age:18-70
•Informed written consent.
Participant with ABI (experiment A4):
•Diagnosed with acquired brain injury
•Age 50-70
•Informed written consent.
Exclusion criteria
Any of the following criteria will lead to exclusion from participation:
Participant without vision loss (healthy control participant; experiment O, A1)
•eye disease
•family history of glaucoma
•neurological disorder
•cognitive impairment: MoCa score: score < 24; TOSSA screening test score < 5th
percentile.
Participant with Glaucoma (A2)
-neurological disorder
-cognitive impairment: MoCa score: score < 24; TOSSA screening test score < 5th
percentile.
Participant with ABI (experiment A3):
•eye disease
•glaucoma
Participant with ABI (experiment A4):
•eye disease
•cognitive impairment: MoCa score: score < 24; TOSSA screening testscore < 5th
percentile.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | 202000003 |
CCMO | NL70382.042.20 |