Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.

NCT ID: NCT02633228

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

2014-12-31

Study Completion Date

2016-06-30

Brief Summary

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The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive 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 Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D in the distance-dominant eye and +3.0 D in the fellow eye.

Intervention Type DEVICE

Other Intervention Names

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Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D (LU-313 MF20T/LS-313 MF20) and +3.0 D (LU-313 MF30T/LS-313 MF30) 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, PhD

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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Alio JL, Plaza-Puche AB, Javaloy J, Ayala MJ, Vega-Estrada A. Clinical and optical intraocular performance of rotationally asymmetric multifocal IOL plate-haptic design versus C-loop haptic design. J Refract Surg. 2013 Apr;29(4):252-9. doi: 10.3928/1081597X-20130318-04.

Reference Type BACKGROUND
PMID: 23557223 (View on PubMed)

Bonaque-Gonzalez S, Rios S, Amigo A, Lopez-Gil N. Influence on Visual Quality of Intraoperative Orientation of Asymmetric Intraocular Lenses. J Refract Surg. 2015 Oct;31(10):651-7. doi: 10.3928/1081597X-20150922-01.

Reference Type BACKGROUND
PMID: 26469073 (View on PubMed)

Garcia-Domene MC, Felipe A, Peris-Martinez C, Navea A, Artigas JM, Pons AM. Image quality comparison of two multifocal IOLs: influence of the pupil. J Refract Surg. 2015 Apr;31(4):230-5. doi: 10.3928/1081597X-20150319-02.

Reference Type BACKGROUND
PMID: 25884577 (View on PubMed)

Alio JL, Plaza-Puche AB, Pinero DP. Rotationally asymmetric multifocal IOL implantation with and without capsular tension ring: refractive and visual outcomes and intraocular optical performance. J Refract Surg. 2012 Apr;28(4):253-8. doi: 10.3928/1081597X-20120314-01.

Reference Type BACKGROUND
PMID: 22496436 (View on PubMed)

Munoz G, Albarran-Diego C, Javaloy J, Sakla HF, Cervino A. Combining zonal refractive and diffractive aspheric multifocal intraocular lenses. J Refract Surg. 2012 Mar;28(3):174-81. doi: 10.3928/1081597X-20120215-02.

Reference Type BACKGROUND
PMID: 22373031 (View on PubMed)

Other Identifiers

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EA2/129/14

Identifier Type: -

Identifier Source: org_study_id

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