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Completed

NCT Number: NCT02633228

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Device

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.

Other names: Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D (LU-313 MF20T/LS-313 MF20) and +3.0 D (LU-313 MF30T/LS-313 MF30) are used.

Primary outcomes

  1. Visual acuities in the far, intermediate and near

    Time frame: 1 month

    Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

  2. Visual acuities in the far, intermediate and near

    Time frame: 3 months

    Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).

  3. Mesopic vision

    Time frame: 1 month

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

  4. Mesopic vision

    Time frame: 3 months

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

  5. Scotopic contrast sensitivity

    Time frame: 1 month

    Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

  6. Scotopic contrast sensitivity

    Time frame: 3 months

    Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.

Secondary outcomes

  1. Spectacle independence in the far, intermediate and near

    Time frame: 3 months

    Spectacle independence as stated by the patient.

Sponsors and collaborators

Lead sponsor

PD Dr. med. Eckart Bertelmann

Other

Registry information

Official study title

Evaluation of the Visual Acuity After the Implantation of an Oculentis +2.0 Diopters (Torical) Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF20T/LS-313 MF20) in the Distance Dominant Eye, in Combination With a +3.0 Diopters Oculentis Bifocal Intraocular Lens (MplusX (Toric) LU-313 MF30T/LS-313 MF30) in the Fellow Eye.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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