Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.

PD Dr. med. Eckart Bertelmann15 enrolled

Overview

The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.0 D and +3.0 D refractive multifocal intraocular lenses.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lensesDEVICE

Binocular implantation of the combination of Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D in the distance-dominant eye and +3.0 D in the fellow eye.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, Germany

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 3 months

Mesopic vision

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

Time frame: 1 month

Mesopic vision

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

Time frame: 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.

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

Spectacle independence in the far, intermediate and near

Spectacle independence as stated by the patient.

Time frame: 3 months

Data from ClinicalTrials.gov

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