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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633072

Enrollment

Registered

2015-12-17

Start date

2014-09-30

Completion date

2016-12-31

Last updated

2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

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

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.

Interventions

DEVICEBinocular 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Visual acuities in the far, intermediate and near	1 month	Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).
Mesopic vision	1 month	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
Scotopic contrast sensitivity	1 month	Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Secondary

Measure	Time frame	Description
Spectacle independence in the far, intermediate and near	3 months	Spectacle independence as stated by the patient.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026