To determine the influence of MFIOL on standard automated perimetry.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the influence of MFIOL on standard automated perimetry test
results with the default stimulus size (size III).
Secondary outcome
To study the effect of a larger stimulus size (size V). Here the hypothesis is
that a larger stimulus is less prone to optical imperfections (like that of a
MFIOL).
Background summary
The aim of this study is to investigate the influence of multifocal intraocular
lenses (MFIOL) on standard automated perimetry (SAP). SAP is the main test for
the diagnosis and the follow-up of glaucoma, a progressive eye disease that may
result in blindness if left untreated. SAP measures contrast sensitivity which
declines due to both glaucoma and age, the latter through age-related changes
in the eye optics and retinal aging.
In young eyes, crystalline lenses are clear, flexible and can accommodate to
focus on images nearby and in a distance. Later on, accommodation is no longer
possible and reading glasses are needed. MFIOL is nowadays more frequently
implanted after cataract extraction to avoid the need of reading glasses. A
major drawback of the MFIOL, however, is loss of contrast sensitivity. As the
prevalence of MFIOL will increase in time, we need to know how this new lens
influences SAP, in order to be able to diagnose and monitor glaucoma in
patients with a MFIOL.. Therefore, the aim of this study, described in this
protocol, is to compare age-matched normative perimetry data of healthy
subjects with subjects with a MFIOL implant.
Study objective
To determine the influence of MFIOL on standard automated perimetry.
Study design
Case-control study
Study burden and risks
A single visit in which SAP is performed and a few additional tests to verify
the healthy state of the eye. Total time investment 1 hour. It is possible that
an eye disease will be discovered during the course of this study. The
resulting psychological distress for the subject can be a disadvantage.
However, the advantage can be an earlier adequate treatment. All the
measurements are performed with optical techniques which do not touch the eye
and are therefore completely harmless and thus there is no risk during the
experiments. No mydriasis (pupil dilatation) will be performed.
Hanzeplein 1
Postbus 30.001 9700 RB Groningen
NL
Hanzeplein 1
Postbus 30.001 9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Human subjects aged 18 and above, with a maximum of 70 years, who are able and willing to participate in this study
Exclusion criteria
Best correct visual acuity (BCVA) of <0.8 or <0.67 when aged above 50
Repeatable visual field defects detected with perimetry
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 | NL39274.042.11 |