Development of a method and diagnostic instrumentation for characterizing the peripheral ocular characteristics of normal subjects (with healthy eyes) in a clinical setting.Primary objective of the study: To measure the distribution of the ocular…
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Ocular geometry measurement using MRI imaging and ocular biometry
The main study parameters are the 3D-shape of the eye and the distances and
curvature between the front and back cornea, the front and back of the
crystalline lens, the equator of the eye, the retina and the sclera. From these
parameters we will derive the variation between those parameters within the
group and correlate them to the results from the current ophthalmology
measures.
Secondary outcome
2. Clinical method to evaluate natural peripheral vision in patients.
The main study parameters are visual acuity, refraction, central and peripheral
wavefront measurements.
Background summary
Cataract is the leading cause of blindness worldwide (39%, World Health
Organization, 2010). Every year over 15 million people worldwide have cataract
surgery performed. When a patient undergoes cataract surgery, the cataractous
lens is removed and replaced with a prosthetic lens known as an intraocular
lens (IOL). Current technology IOLs restore central vision adequately, however,
it has been discovered recently that the image quality in the peripheral field
of view is significantly reduced by current IOLs. This has potential
implications for everyday tasks, such as walking, car driving and manoeuvring
in low light conditions. Improving peripheral vision obtained with IOLs may
increase postoperative quality of life.
Study objective
Development of a method and diagnostic instrumentation for characterizing the
peripheral ocular characteristics of normal subjects (with healthy eyes) in a
clinical setting.
Primary objective of the study:
To measure the distribution of the ocular geometry of eyes of the healthy
population using MRI imaging and ocular biometry. Investigate the variance in
the eye shape of young and old subjects.
Next to this, we will verify wether the ocular geometrie is changed by the
insertion of an intraocular lens.
Secondary objective of the study:
To establish a clinical method to evaluate natural peripheral vision in
patients.
Study design
The study is a single center quantitative cross-sectional study to measure the
natural geometry and peripheral ocular characteristics of the eye. The study
will consists of a group of 90 subjects.
The subjects will undergo a MRI scan protocol at the 7 Tesla Philips scanner
followed by an extensive ophthalmic evaluation. The cataract patients will
furthermore receive an additional MRI scan protocol prior to the cataract
surgery.
Study burden and risks
The risks of this study are the standard risks related to MRI. These risks will
be minimized by screening the subjects through a questionnaire for MRI safety
via telephone two weeks before the study day and prior to the examination. The
questionnaire will cover the risk factors associated with MRI. Based on the
answers, the subject will be allowed or not allowed to go into the scanner.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
subjects with virgin eyes or patients undergoing cataract surgery
Exclusion criteria
Healthy volunteers:
ocular pathology
prior intra- or extraocular surgery
contra-dindication to MRI scanning;Cataract patients:
ocular pathology other than cataract
prior intra- or extraocular surgery
contra-dindication to MRI scanning
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45166.058.13 |