The primary objective is to determine psychometric properties of the NEI-VFQ 25 in patients with uveitis, The secondary objectives will be to determine the impact of uveitis on the daily visual functioning of uveitis patients.
ID
Source
Brief title
Condition
- Eye disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
content validity
scale structure
internal consistency (cronbach alpha)
test- retest reliability (interclass correlation coefficient)
construct validity
responsiveness
(paragraph 7.4 protocol)
Secondary outcome
composite score NEI-VFQ 25
subscale scores NEI-VFQ 25
(paragraph 7.5 protocol)
Background summary
Uveitis is a chronic eye disease and an important cause of ocular morbidity.
Population based estimates of its true incidence and prevalence in the
Netherlands are unfortunately not available. Severe forms of uveitis often lead
to visual impairment and blindness. In surveys of the causes of blindness
uveitis is usually not included and is probably underestimated. The
complications of uveitis like glaucoma, cataract and cystoid macular oedema are
considered to be the direct cause, while the primary cause of the decrease in
visual acuity (uveitis) is not mentioned.
We believe that for uveitis research it is important to find a method of
measurement that emphasizes all different aspects of visual disability that
patients identify as being important for their daily functioning. The
traditional clinical measures of vision, such as Snellen visual acuity fail to
assess many of these aspects, such as emotional well-being and social
functioning. The review article of de Boer et al. revealed that the VCM1, the
IVI and the NEI-VFQ 25 show the highest psychometric quality for people with
visual impairments in general. From these three questionnaires the NEI- VFQ is
the only one that encloses all four dimensions of quality of life (functional,
social, psychological and physical).
The NEI-VFQ 25 is a widely used questionnaire that is tested for reliability
and validity in patients with cataract, age related macular degeneration,
diabetic retinopathy, primary open angle glaucoma, cytomegalovirus retinitis
and low vision, but is not yet tested in uveitis patients..
Study objective
The primary objective is to determine psychometric properties of the NEI-VFQ 25
in patients with uveitis,
The secondary objectives will be to determine the impact of uveitis on the
daily visual functioning of uveitis patients.
Study design
For this propective study we will recruite 300 patients from 7 European and 2
American sites and divide them into two groups, one with patients with acute
and one with patients with chronic autoimmune uveitis due to one of the
following causes: ocular sarcoidosis, intermediate uveitis, Behcet's syndrome,
idiopathic retinal vasculitis, birdshot chorioretinopathy or
Vogt-Kayanaki-Harada disease/ sympathetic opthalmia. The three different
language groups in this study will be analysed separately to prevent bias due
to translation differences.
Eligible participants will be asked to come for two visits (baseline and six
month visit) on both visits they will undergo a complete ocular examination and
will be asked to fill the SF-36 and the NEI-VFQ 25 questionnaire.
A subgroup of 30 patients will be asked to come for an extra visit between two
to four weeks from baseline. This data will be used to test the test-retest
reliability of the NEI-VFQ 25.
Study burden and risks
-
Meibergdreef 9
1100 DD Amsterdam
Nederland
Meibergdreef 9
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Men and women *18 years with non-infectious uveitis due to one of the following causes: sarcoidosis, intermediate uveitis, Behcet's syndrome, idiopathic retinal vasculitis, birdshot chorioretinopathy, Vogt-Koyanaki-Harada disease or sympathetic ophthalmia, who meet the SUN criteria for acute uveitis.
2. Men and women *18 years with non-infectious uveitis due to one of the following causes: sarcoidosis, intermediate uveitis, Behcet's syndrome, idiopathic retinal vasculitis, birdshot chorioretinopathy, Vogt-Koyanaki-Harada disease or sympathetic ophthalmia, who meet the SUN criteria for chronic uveitis.
Exclusion criteria
Age < 18 years.
Inability to understand the questionnaire.
Inability to be seen 6 months after initial visit.
Inability to understand or sign the informed consent
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 | NL12297.018.06 |