Clinical Trials Directory

Trials / Completed

CompletedNCT03292614

Measurement of Refractive SE Following Implantation of LS313 MF30 IOL

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
Dietrich-Bonhoeffer-Klinikum · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTMeasurements of the postoperative refractionThe 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)

Timeline

Start date
2017-06-01
Primary completion
2019-01-31
Completion
2019-06-01
First posted
2017-09-25
Last updated
2019-09-26
Results posted
2019-09-26

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03292614. Inclusion in this directory is not an endorsement.