Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

Study Overview
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Brief Summary
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This Study determines the most precise method for measuring post-operative refraction following implantation of the asymmetric multifocal LS-313 MF30 comparing the results of Refraction of the different Autorefractor Keratometers with the subjective measurements for distance and near.

Detailed Description
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This is a post market study without invasive interventions. The patients have been treated with cataract surgery and MIOL Implantation at least 3 months ago. They will be invited for only one follow up visit to measure the postoperative refraction with different Autorefractor-Keratometers, a Manual Refractometer, the test device iTrace and with determination of the subjective refraction for distance and near with the appropriate corrections at the Department of Ophthalmology in Neubrandenburg, Germany.

Official Title
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Measurement of Refraction Following Cataract Surgery With Implantation of MICS Intraocular Lens LS313 MF30, Oculentis Berlin

Conditions
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Refractive Errors

Intervention / Treatment
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* Diagnostic Test: Measurements of the postoperative refraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after cataract surgery with implantation of the MICS-IOL LS-313 MF30 postoperative clear cornea willing to participate in the study Exclusion Criteria: significant corneal opacities, history of keratoplasty, Anterior capsule phimosis, posterior capsular opacification if patients refuse Nd:YAG laser treatment of the secondary cataract

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multifocal intraocular lens implantation<br>Patients who have undergone a cataract surgery with implantation of a multifocal intraocular lens LS313 MF30, Oculentis Berlin, will be invited for Measurements of the postoperative refraction | Diagnostic Test: Measurements of the postoperative refraction<br>* The Measurements of the postoperative refraction will be performed with the following devices: Autorefractor Keratometers: Mod. ARK-760A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany), Mod. ARK-560A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany) KR-1W (TOPCON, Willich, Germany) KR-800s (TOPCON, Willich, Germany) Manual Refractometer: Eye refractometer PR 60 or PR 50 (Rodenstock, Munich), Test device: iTrace (TraceyTechnologies, Houston, Texas, USA), Phoropter (Block-Optic, Model 11625B) Determination of subjective refraction for distance and near (reading distance)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30 | After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction. A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)). KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones. The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter. The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm. The results of all refractometers are compared with the subjective refraction. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multifocal Intraocular Lens, Postoperative Measurements of refraction