Dissection of etiology of myopia- identification of genetic risk factors- identification of environmental risk factors- evaluation of the long term safety of Artisan phakic intraocular lenses for the correction of high degree myopia
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters:
- Single nucleotide polymorphisms (SNPs) or mutations
Primary outcome variable:
- High myopia present/absent
Secondary outcome
Secondary study parameters:
- environmental risk factors such as reading in youth, education, refractive
error of parents etc
- range of accommodation
Secondary outcome variable:
- refraction as continuous variable
- axial length
- cornea curvature, anterior chamber length
- complications of myopia such as glaucoma, retinal defects, staphyloma and
macular degeneration
- safety of phakic Artisan intraocular lenses
Background summary
Myopia, or shortsightedness, is a frequent eye disorder that may lead to
blindness. There are currently no treatment options to stop progression or cure
the complications. The many animal studies on this topic have not revealed the
causes of myopia in humans. From epidemiologic studies it has become clear that
the disease is highly heritable. The current hypothesis is that myopia is a
complex genetic disorder probably consisting of multiple genes with relatively
small effect. Therefore, large studies with substantial statistical power are
needed.
Study objective
Dissection of etiology of myopia
- identification of genetic risk factors
- identification of environmental risk factors
- evaluation of the long term safety of Artisan phakic intraocular lenses for
the correction of high degree myopia
Study design
This study will consist of 600 subjects with high myopia (more than -6
diopters), 600 control subjects, and 150 family members of cases with high
myopia. All subjects will undergo a complete ophthalmologic examination
including visual acuity, refractive error, axial length, keratometry, stray
light measurement, anterior segment analysis (cornea cell count and position of
implant lens), photography of the retina, and an OCT (measures thickness of the
retina). We will elucidate family pedigrees, draw blood for DNA analysis, and
use a questionnaire to ask about course of progression and environmental
factors (education, socio-economic status, occupation, smoking, diet, reading
habits and outside activities in youth).
Study burden and risks
The time investment and the effects after mydriasis of the pupils form the most
important burden.
's Gravendijkwal 230 's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230 's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Persons aged 18 years or older, high myopic from SE -6D and higher, and persons with SE -1.5 D to +1.5 D.
Exclusion criteria
younger then age 18; refractive error between SE -1.5 D and -5.75 D; or refractive error SE > 1.5 D
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 | NL28647.078.09 |