To create a registry for paediatric patients with iris-fixated or posterior IOL*s, and the assessment of the long-term effects of implanted, artificial lenses in children.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of endothelial damage and endothelial cell density.
Secondary outcome
Vision.
Axial length of the eye.
Incidence of chronic anterior uveitis.
Background summary
In The Rotterdam Eye Hospital, paediatric patients with aphakia after surgery
for lens luxation due to Marfan*s disease, homocysteinuria or ectopia lentis et
pupillae receive an iris-fixated lens, while children with congenital or
juvenile cataract receive a posterior, 'in the bag', intraocular lens (IOL).
The relative proximity of iris-fixated lenses to the corneal endothelium may
affect its condition, and thereby vision, in the long term. In this study data
will be systematically collected to create a registry for paediatric patients
with an artificial IOL.
Study objective
To create a registry for paediatric patients with iris-fixated or posterior
IOL*s, and the
assessment of the long-term effects of implanted, artificial lenses in
children.
Study design
Observational.
Study burden and risks
Participants do not benefit, risks are negligible, study procedures are
non-invasive and take about 45 minutes extra time form patient and parent,
annually.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Paediatric patients (4-15 years of age) with aphakia, iris-fixated or posterior IOLs.
Exclusion criteria
No 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 | NL32307.078.10 |