The first aim of this study is to evaluate a number of new perimetric methods regarding their ability to detect glaucomatous visual field defects without being stressful or difficult for older participants. In this first study, both controls and…
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The output of each perimetric device and of the feedback questionnaire.
Secondary outcome
N/A
Background summary
Glaucoma is a progressive optical neuropathy that affects older adults, and it
is one of the main causes of irreversible blindness if not treated. Standard
Automatic Perimetry (SAP) is the most common visual field technique used to
diagnose and monitor the progression of pathology, but in older patients it has
some limitations. Firstly, normative data is missing in elderly patients - most
databases contain only patients up to 70 years. Secondly, although some
patients experience a normal cognitive decline due to age, it is often the case
that more serious motor and/or cognitive disorders also occur. For these two
reasons, we need (1) normative data for older people and (2) devices that are
more user-friendly than current technologies. In this study we will compare
five new field field measurements with the gold standard. Then we collect
normative data for the best two tests, which are accordingly chosen for their
user-friendliness and distinctiveness.
Study objective
The first aim of this study is to evaluate a number of new perimetric methods
regarding their ability to detect glaucomatous visual field defects without
being stressful or difficult for older participants. In this first study, both
controls and glaucoma patients will undergo a neuropsychological screening test
to exclude any cognitive impairment. We determine for each new technique (1)
whether the test score differs between the glaucoma patients and the controls
and (2) the user-friendliness. For the latter, we use a feedback questionnaire.
Hereafter we select the tests that meet both of the above requirements
(distinctiveness and user-friendliness) and we use these to collect and apply
normative data in 100 healthy subjects to 100 glaucoma patients. This allows us
to determine the sensitivity at a fixed specificity of 95%, a common value in
glaucoma care. In a follow-up study that is not included in this application,
we will apply the selected devices to older people with cognitive and/or motor
conditions.
Study design
Observational cross-section study
Study burden and risks
Glaucoma patients and healthy subjects will have to visit the ophthalmology
department to perform the screening tests, and, if selected, the visual field
tests selected for the experiment. Healthy subjects will undergo a routine
ophthalmic screening test to rule out the presence of glaucoma. Glaucoma
patients will not perform any ophthalmic screening, therefore there is no risk
of identifying any other eye conditions. Both glaucoma patients and healthy
subjects will then undergo a neuropsychological screening test to rule out the
presence of any pathological cognitive impairment. If any abnormal screening
results are obtained in any of the two screenings, they will be referred to
their GP. Detection of signs of an eye condition or cognitive deficit may cause
psychological stress, however, an early diagnosis will allow treatments to be
initiated and therefore more preservation of visual or cognitive functioning.
Participants who meet the selection criteria will then undergo the selected
battery of visual field tests. Patients and healthy subjects will spend 21.5
hours and 2.5 hours in our lab, respectively, to complete the required tasks.
Subjects with glaucoma will be recruited from a population of glaucoma patients
who visit the ophthalmology clinic at the UMCG. For the recruitment of healthy
subjects, we will invite the spouses of the patients and will place poster
adverts in and around the UMCG.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
70-95 years of age
Written informed consent
For healthy subjects: questionnaire results that do not indicate the presence of any ophthalmic abnormality, no cognitive impairment detected in the MoCA
For glaucoma patients: diagnosed glaucoma, no cognitive impairment in the MoCA
Exclusion criteria
For healthy subjects: MoCA score below 26; any eye disease/visual field loss; intraocular pressure above 21 mmHg; family history of glaucoma.
For glaucoma patients: MoCA score below 26; non-glaucomatous visual field loss.
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 |
---|---|
CCMO | NL60939.042.17 |
Other | UMCG register 201700338 |