Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-06-01

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.

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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.

Conditions

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Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multifocal intraocular lens implantation

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

Measurements of the postoperative refraction

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

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Measurements of the postoperative refraction

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)

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No