Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

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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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dietrich-Bonhoeffer-Klinikum

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurements of the postoperative refraction

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)

Primary outcomes

Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30

Time frame: one year

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.

Sponsors and collaborators

Lead sponsor

Dietrich-Bonhoeffer-Klinikum

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Sep 25, 2017
Registry last updated: Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed