Clinical trial NCT03292614: Measurement of Refractive SE Following Implantation of LS313 MF30 IOL
Official title: Measurement of Refraction Following Cataract Surgery With Implantation of MICS Intraocular Lens LS313 MF30, Oculentis Berlin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Keywords: Multifocal Intraocular Lens
Postoperative Measurements of refraction
Lead sponsor: Dietrich-Bonhoeffer-Klinikum
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: up to 100 eyes

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum
state: Mecklenburg/Vorpommern
Study officials:
affiliation: Department of Ophthalmology, Neubrandenburg, Germany
name: Helmut Hoeh, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, Neubrandenburg, Germany
name: Vitaliy Klishko
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.