Clinical trial NCT02633072: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Multifocal Intraocular Lens
Binocular Trifocality
Cataract Surgery
Spectacle Independence
Intermediate Vision
Photopic Vision
Mesopic Vision
Scotopic Vision
Binocular Vision
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual acuities in the far, intermediate and near
timeFrame: 1 month
measure: Visual acuities in the far, intermediate and near
timeFrame: 3 months
measure: Mesopic vision
timeFrame: 1 month
measure: Mesopic vision
timeFrame: 3 months
measure: Scotopic contrast sensitivity
timeFrame: 1 month
measure: Scotopic contrast sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: Spectacle independence in the far, intermediate and near
timeFrame: 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin, Department of Ophthalmology
Study officials:
affiliation: Charité - University Medicine Berlin, Department of Ophthalmology
name: Eckart Bertelmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.