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

NCT02633072 | Completed Phase 4

• 1 other identifier: EA1/171/14
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Mesopic vision

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

  1 month

• Mesopic vision

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

  3 months

• 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

• 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 Outcomes (1)

• Spectacle independence in the far, intermediate and near

  3 months

Interventions

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr. med. Eckart Bertelmann: lead

Study Sites (1)

Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, 1335, Germany

Location

Related Publications (5)

• 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.

  PMID: 25974967 BACKGROUND

• 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.

  PMID: 25987651 BACKGROUND

• 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.

  PMID: 26098463 BACKGROUND

• 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.

  PMID: 26562168 BACKGROUND

• 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.

  PMID: 26209232 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Eckart Bertelmann, MD

  Charité - University Medicine Berlin, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 17, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Locations

DE (1)