To evaluate the long term safety, efficacy, predictability, stability, complications and patient satisfaction after implantation of Artisan phakic intraocular lenses for the correction of high degree myopia.
ID
Source
Brief title
Condition
- Eye disorders NEC
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the safety, efficacy and predictability of visual outcome up to 15
years post-surgery, after an Artisan pIOL implantation for the correction of
high degree myopia.
- Safety defined as >= 2 lines loss of the best spectacle corrected visual
acuity in percentage compared to pre-surgery.
- Efficacy defined as the percentage of eyes with an uncorrected visual acuity
>= 20/20.
- Predictability defined the manifest refractive spherical equivalent within
+/- 1.0 diopters of the intended correction.
Secondary outcome
- Determine complications of an Artisan pIOL, in particular endothelial cell
loss
- Determine the stability of an Artisan pIOL for the correction of high degree
myopia by comparing short term data with long term data
- Observe long term complications associated with high degree myopia
- Determine the patients* satisfaction up to 15 years post-surgery after
implantation of an Artisan pIOL
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 causes of high myopia are still unknown. 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.
There are currently no treatment options available for stopping the progression
of myopia. The optical correction of myopia can be achieved by spectacle
lenses, contact lenses or by implantation of an intraocular lens.
Phakic intraocular lenses (pIOL) are implanted into the human eye in addition
to the natural ocular lens. There are many different kinds of intraocular
lenses. In 1998 the Artisan pIOL was introduced. The Artisan is a
concave-convex phakic intraocular lens and is designed to be supported by the
mid-iris tissue, also called an *iris claw*. Multiple short term follow up
studies have shown that the Artisan pIOL is a safe and efficient method for
correction of high myopia.
Only a limited amount of studies have been performed to evaluate the long term
safety, efficacy, stability, predictability, complications and patient
satisfaction of an Artisan iris claw phakic intraocular lens for correction of
high degree myopia. Even fewer studies have evaluated the results after a post
operative follow-up up to ten years. Evaluation of the long-term outcomes of
implantation of an Artisan will help us determine the safety of this device.
Insights into the long-term outcomes of implantation of an Artisan pIOL will
help us determine the safety of this device and may help modification and
development of future intraocular lenses for correction of high degree myopia.
Study objective
To evaluate the long term safety, efficacy, predictability, stability,
complications and patient satisfaction after implantation of Artisan phakic
intraocular lenses for the correction of high degree myopia.
Study design
The design is a retrospective observational study in which we will collect data
on outcomes regarding the safety, efficacy, predictability, stability,
complications and patient satisfaction in patients treated for high degree
myopia with an Artisan iris fixated phakic intra ocular lens implant.
Study burden and risks
not applicable
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- minimum 18 years of age and fully competent
- Sign an informed consent to participate in this study
- Artisan iris fixated phakic intra ocular lens implant for optical correction of high degree myopia ( > S-6 diopters)
- Minimal postoperative follow up of 5 years
- Endothelial cell count performed pre-operative
Exclusion criteria
none
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 | NL32857.058.10 |