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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Diagnostic test: Measurements of the postoperative refraction

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg/Vorpommern
    • Neubrandenburg, Mecklenburg/Vorpommern, Germany, 17036
      • Dietrich-Bonhoeffer-Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

up to 100 eyes

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dietrich-Bonhoeffer-Klinikum
• Investigators: Principal Investigator: Helmut Hoeh, MD, FEBO, Department of Ophthalmology, Neubrandenburg, Germany; Study Chair: Vitaliy Klishko, Department of Ophthalmology, Neubrandenburg, Germany

Publications and helpful links

General Publications

• Kretz FT, Linz K, Mueller M, Gerl M, Koss MJ, Gerl RH, Auffarth GU. [Refraction after Implantation of Multifocal and Presbyopia-Correcting Intraocular Lenses]. Klin Monbl Augenheilkd. 2015 Aug;232(8):953-6. doi: 10.1055/s-0035-1545832. Epub 2015 Apr 30. German.
• Munoz G, Albarran-Diego C, Sakla HF. Validity of autorefraction after cataract surgery with multifocal ReZoom intraocular lens implantation. J Cataract Refract Surg. 2007 Sep;33(9):1573-8. doi: 10.1016/j.jcrs.2007.05.024.
• Bissen-Miyajima H, Minami K, Yoshino M, Nishimura M, Oki S. Autorefraction after implantation of diffractive multifocal intraocular lenses. J Cataract Refract Surg. 2010 Apr;36(4):553-6. doi: 10.1016/j.jcrs.2009.10.047.
• van der Linden JW, Vrijman V, Al-Saady R, van der Meulen IJ, Mourits MP, Lapid-Gortzak R. Autorefraction versus subjective refraction in a radially asymmetric multifocal intraocular lens. Acta Ophthalmol. 2014 Dec;92(8):764-8. doi: 10.1111/aos.12410. Epub 2014 Apr 27. Erratum In: Acta Ophthalmol. 2015 Feb;93(1):e82. El-Saady, Rana [corrected to Al-Saady, Rana].
• Munoz G, Albarran-Diego C, Sakla HF. Autorefraction after multifocal IOLs. Ophthalmology. 2007 Nov;114(11):2100. doi: 10.1016/j.ophtha.2007.05.049. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Multifocal Intraocular Lens; Postoperative Measurements of refraction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: STI 02/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results will be published in ophthalmological journals (Individual participant date will not be provided).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No