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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633072
• Other study ID #: EA1/171/14
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2015
• Last updated: June 28, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses
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.

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin, Department of Ophthalmology	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
PD Dr. med. Eckart Bertelmann

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View Citation

Kretz FT, Gerl M, Gerl R, Müller 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. — View 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. — View Citation

Vega F, Alba-Bueno F, Millán MS, Varón 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. — View Citation

Vega F, Millán 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month
Primary	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).	3 months
Primary	Mesopic vision	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.	1 month
Primary	Mesopic vision	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.	3 months
Primary	Scotopic contrast sensitivity	Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.	1 month
Primary	Scotopic contrast sensitivity	Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.	3 months
Secondary	Spectacle independence in the far, intermediate and near	Spectacle independence as stated by the patient.	3 months