Visual Acuity After the Combined Binocular Implantation of +2.75 Diopters and +3.25 Diopters Tecnis Multifocal Intraocular Lenses.

NCT ID: NCT02633072

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

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The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.75 D and +3.25 D full-diffractive multifocal intraocular lenses.

Detailed Description

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Bifocal multifocal intraocular lenses (MIOL) are effective in achieving good uncorrected visual acuities in the distance and the near. However, the intermediate vision is of increasing relevance for everyday's life. Several multifocal intraocular lenses have been developed to improvement intermediate vision. Nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. Therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Binocular implantation of the combination of AMO® Tecnis® multifocal intraocular lenses with an addition of +2.75 D in the distance-dominant eye and +3.25 D in the fellow eye.

Intervention Type DEVICE

Other Intervention Names

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AMO® Tecnis® multifocal intraocular lenses with an addition of +2.75 D (ZKB00) and +3.25 D (ZLB00) are used.

Eligibility Criteria

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Inclusion Criteria

* clinically significant cataract
* endothelial cell count: patients aged 18-75 years: \> 1000 cells/mm2; patients \> 75 years: \> 750 cells/mm2
* absence of vision-limiting corneal or retinal comorbidities
* capability to understand the informed consent

Exclusion Criteria

* expected postoperative astigmatism \> 0.75 diopters
* irregular astigmatism
* dilated pupil diameter \< 3 mm
* corneal and fundus abnormalities that might cause visual impairments
* inability to attend follow-up visits
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PD Dr. med. Eckart Bertelmann

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. med. Eckart Bertelmann

Senior Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eckart Bertelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Charité - University Medicine Berlin, Department of Ophthalmology

Locations

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Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, , Germany

Site Status

Countries

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Germany

References

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Kretz FT, Koss MJ, Auffarth GU; ZLB00 Study Group. Intermediate and near visual acuity of an aspheric, bifocal, diffractive multifocal intraocular lens with +3.25 D near addition. J Refract Surg. 2015 May;31(5):295-9. doi: 10.3928/1081597X-20150423-02.

Reference Type BACKGROUND
PMID: 25974967 (View on PubMed)

Kretz FT, Gerl M, Gerl R, Muller M, Auffarth GU; ZKB00 Study Group. Clinical evaluation of a new pupil independent diffractive multifocal intraocular lens with a +2.75 D near addition: a European multicentre study. Br J Ophthalmol. 2015 Dec;99(12):1655-9. doi: 10.1136/bjophthalmol-2015-306811. Epub 2015 May 18.

Reference Type BACKGROUND
PMID: 25987651 (View on PubMed)

Vega F, Alba-Bueno F, Millan MS, Varon C, Gil MA, Buil JA. Halo and Through-Focus Performance of Four Diffractive Multifocal Intraocular Lenses. Invest Ophthalmol Vis Sci. 2015 Jun;56(6):3967-75. doi: 10.1167/iovs.15-16600.

Reference Type BACKGROUND
PMID: 26098463 (View on PubMed)

Vega F, Millan MS, Vila-Terricabras N, Alba-Bueno F. Visible Versus Near-Infrared Optical Performance of Diffractive Multifocal Intraocular Lenses. Invest Ophthalmol Vis Sci. 2015 Nov;56(12):7345-51. doi: 10.1167/iovs.15-17664.

Reference Type BACKGROUND
PMID: 26562168 (View on PubMed)

Kim JS, Jung JW, Lee JM, Seo KY, Kim EK, Kim TI. Clinical Outcomes Following Implantation of Diffractive Multifocal Intraocular Lenses With Varying Add Powers. Am J Ophthalmol. 2015 Oct;160(4):702-9.e1. doi: 10.1016/j.ajo.2015.07.021. Epub 2015 Jul 21.

Reference Type BACKGROUND
PMID: 26209232 (View on PubMed)

Other Identifiers

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EA1/171/14

Identifier Type: -

Identifier Source: org_study_id

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