ong-term follow up after implantation of Artisan Phakic Iris Claw Intraocular lens for the correction of high degree myopia
Completed
- Conditions
- myopiashortsightedness1001591710043413
- Registration Number
- NL-OMON39608
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the safety, efficacy and predictability of visual outcome up to 15<br /><br>years post-surgery, after an Artisan pIOL implantation for the correction of<br /><br>high degree myopia.<br /><br><br /><br>- Safety defined as >= 2 lines loss of the best spectacle corrected visual<br /><br>acuity in percentage compared to pre-surgery.<br /><br>- Efficacy defined as the percentage of eyes with an uncorrected visual acuity<br /><br>>= 20/20.<br /><br>- Predictability defined the manifest refractive spherical equivalent within<br /><br>+/- 1.0 diopters of the intended correction.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Determine complications of an Artisan pIOL, in particular endothelial cell<br /><br>loss<br /><br>- Determine the stability of an Artisan pIOL for the correction of high degree<br /><br>myopia by comparing short term data with long term data<br /><br>- Observe long term complications associated with high degree myopia<br /><br>- Determine the patients* satisfaction up to 15 years post-surgery after<br /><br>implantation of an Artisan pIOL</p><br>