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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

About this trial

This is an interventional treatment trial for Cataract focused on measuring Multifocal Intraocular Lens, Binocular Trifocality, Cataract Surgery, Spectacle Independence, Intermediate Vision, Photopic Vision, Mesopic Vision, Scotopic Vision, Binocular Vision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charité - University Medicine Berlin, Department of Ophthalmology

Outcomes

Primary Outcome Measures

Visual acuities in the far, intermediate and near

Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

Visual acuities in the far, intermediate and near

Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

Mesopic vision

Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.

Mesopic vision

Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.

Scotopic contrast sensitivity

Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Scotopic contrast sensitivity

Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Secondary Outcome Measures

Spectacle independence in the far, intermediate and near

Spectacle independence as stated by the patient.

Full Information

NCT ID

NCT02633072

First Posted

December 14, 2015

Last Updated

June 28, 2017

Sponsor

PD Dr. med. Eckart Bertelmann

1. Study Identification

Unique Protocol Identification Number

NCT02633072

Brief Title

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

Official Title

Evaluation of the Visual Acuity After the Implantation of a Tecnis +2.75 Diopters Bifocal Intraocular Lens (Tecnis ZKB00) in the Distance Dominant Eye, in Combination With a +3.25 Diopters Tecnis Bifocal Intraocular Lens (Tecnis ZLB00) in the Fellow Eye.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

PD Dr. med. Eckart Bertelmann

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Visual acuities in the far, intermediate and near

Description

Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

Time Frame

1 month

Title

Visual acuities in the far, intermediate and near

Description

Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

Time Frame

3 months

Title

Mesopic vision

Description

Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.

Time Frame

1 month

Title

Mesopic vision

Description

Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.

Time Frame

3 months

Title

Scotopic contrast sensitivity

Description

Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Time Frame

1 month

Title

Scotopic contrast sensitivity

Description

Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Spectacle independence in the far, intermediate and near

Description

Spectacle independence as stated by the patient.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eckart Bertelmann, MD

Organizational Affiliation

Charité - University Medicine Berlin, Department of Ophthalmology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité - University Medicine Berlin, Department of Ophthalmology

City

Berlin

ZIP/Postal Code

1335

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25974967

Citation

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.

Results Reference

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PubMed Identifier

25987651

Citation

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.

Results Reference

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PubMed Identifier

26098463

Citation

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. Erratum In: Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4694.

Results Reference

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PubMed Identifier

26562168

Citation

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.

Results Reference

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PubMed Identifier

26209232

Citation

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.

Results Reference

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

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