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Visual Acuity After the Combined Binocular Implantation of +2.5 Diopters and +3.0 Diopters ReSTOR Multifocal Intraocular Lenses.

NCT ID: NCT02314572

Last Updated: 2015-12-16

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

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.5 D and +3.0 D apodized 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

Keywords

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Multifocal Intraocular Lens Binocular Trifocality Cataract Surgery Spectacle Independence Intermediate Vision Photopic Vision Mesopic Vision Scotopic Vision Binocular Vision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm

Group Type OTHER

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Intervention Type DEVICE

Binocular implantation of the combination of AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D in the distance-dominant eye and +3.0 D in the fellow eye.

Interventions

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Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Binocular implantation of the combination of AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D in the distance-dominant eye and +3.0 D in the fellow eye.

Intervention Type DEVICE

Other Intervention Names

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AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D (SV25-type) and +3.0 D (SN6A-type) 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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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. med. Eckart Bertelmann

managing senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eckart Bertelmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Tobias Brockmann, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Pedrotti E, Mastropasqua R, Passilongo M, Parisi G, Marchesoni I, Marchini G. Comparison of two multifocal intraocular lens designs that differ only in near add. J Refract Surg. 2014 Nov;30(11):754-60. doi: 10.3928/1081597X-20141021-07.

Reference Type BACKGROUND
PMID: 25375848 (View on PubMed)

Alfonso JF, Knorz M, Fernandez-Vega L, Rincon JL, Suarez E, Titke C, Kohnen T. Clinical outcomes after bilateral implantation of an apodized +3.0 D toric diffractive multifocal intraocular lens. J Cataract Refract Surg. 2014 Jan;40(1):51-9. doi: 10.1016/j.jcrs.2013.06.026.

Reference Type BACKGROUND
PMID: 24355720 (View on PubMed)

Javitt JC, Steinert RF. Cataract extraction with multifocal intraocular lens implantation: a multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes. Ophthalmology. 2000 Nov;107(11):2040-8. doi: 10.1016/s0161-6420(00)00368-7.

Reference Type BACKGROUND
PMID: 11054329 (View on PubMed)

Vingolo EM, Grenga P, Iacobelli L, Grenga R. Visual acuity and contrast sensitivity: AcrySof ReSTOR apodized diffractive versus AcrySof SA60AT monofocal intraocular lenses. J Cataract Refract Surg. 2007 Jul;33(7):1244-7. doi: 10.1016/j.jcrs.2007.03.052.

Reference Type BACKGROUND
PMID: 17586381 (View on PubMed)

Cillino G, Casuccio A, Pasti M, Bono V, Mencucci R, Cillino S. Working-age cataract patients: visual results, reading performance, and quality of life with three diffractive multifocal intraocular lenses. Ophthalmology. 2014 Jan;121(1):34-44. doi: 10.1016/j.ophtha.2013.06.034. Epub 2013 Aug 14.

Reference Type BACKGROUND
PMID: 23953097 (View on PubMed)

Chiam PJ, Chan JH, Aggarwal RK, Kasaby S. ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg. 2006 Sep;32(9):1459-63. doi: 10.1016/j.jcrs.2006.04.015.

Reference Type BACKGROUND
PMID: 16931256 (View on PubMed)

Other Identifiers

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EA1/124/13

Identifier Type: -

Identifier Source: org_study_id