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Visual Acuity After the Combined Binocular Implantation of +2.5 Diopters and +3.0 Diopters ReSTOR 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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single-arm

Arm Description

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

NCT02314572

First Posted

December 8, 2014

Last Updated

December 15, 2015

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT02314572

Brief Title

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

Official Title

Evaluation of the Visual Acuity After the Implantation of a ReSTOR +2.5 Diopters Intraocular Lens (ReSTOR SV25T0) in the Distance Dominant Eye, in Combination With a +3.0 Diopters ReSTOR Intraocular Lens (ReSTOR SN6AD1) in the Fellow Eye.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

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 +2.5 D and +3.0 D apodized 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 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-arm

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Other Intervention Name(s)

AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D (SV25-type) and +3.0 D (SN6A-type) are used.

Intervention Description

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.

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, PhD

Organizational Affiliation

eckart.bertelmann@charite.de

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tobias Brockmann, MD

Organizational Affiliation

tobias.brockmann@charite.de

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité - University Medicine Berlin, Department of Ophthalmology

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25375848

Citation

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.

Results Reference

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PubMed Identifier

24355720

Citation

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.

Results Reference

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PubMed Identifier

11054329

Citation

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.

Results Reference

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PubMed Identifier

17586381

Citation

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.

Results Reference

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PubMed Identifier

23953097

Citation

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.

Results Reference

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PubMed Identifier

16931256

Citation

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. Erratum In: J Cataract Refract Surg. 2006 Dec;32(12):1987.

Results Reference

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

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