Long-term follow up after implantation of Artisan Phakic Iris Claw Intraocular lens for the correction of high degree myopia

Long-term follow up after implantation of Artisan Phakic Iris Claw Intraocular lens for the correction of high degree myopia - Long term follow up of an Artisan IOL in high degree myopia / ARTIC-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39608

Enrollment

200

Registered

2010-10-01

Start date

2011-01-20

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia shortsightedness

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
- 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	—

Countries

Netherlands

Outcome results