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Visual Acuity After the Combined Binocular Implantation of +2.5 Diopters and +3.0 Diopters ReSTOR Multifocal Intraocular Lenses.

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ClinicalTrials.gov Identifier: NCT02314572
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. Eckart Bertelmann, Charite University, Berlin, Germany

Study Description
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Brief Summary:
The objective of this study is to assess the visual outcome after the combined binocular implantation of +2.5 D and +3.0 D apodized diffractive multifocal intraocular lenses.

Condition or disease Intervention/treatment Phase
Cataract Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Visual Acuity After the Implantation of a ReSTOR +2.5 Diopters Intraocular Lens (ReSTOR SV25T0) in the Distance Dominant Eye, in Combination With a +3.0 Diopters ReSTOR Intraocular Lens (ReSTOR SN6AD1) in the Fellow Eye.
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Single-arm Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses
Binocular implantation of the combination of AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D in the distance-dominant eye and +3.0 D in the fellow eye.
Other Name: AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D (SV25-type) and +3.0 D (SN6A-type) are used.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Spectacle independence in the far, intermediate and near [ Time Frame: 3 months ]
    Spectacle independence as stated by the patient.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314572


Locations
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Germany
Charité - University Medicine Berlin, Department of Ophthalmology
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Eckart Bertelmann, MD, PhD eckart.bertelmann@charite.de
Principal Investigator: Tobias Brockmann, MD tobias.brockmann@charite.de
More Information
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Publications:

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Responsible Party: PD Dr. med. Eckart Bertelmann, managing senior physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02314572    
Other Study ID Numbers: EA1/124/13
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Keywords provided by PD Dr. med. Eckart Bertelmann, Charite University, Berlin, Germany:
Multifocal Intraocular Lens
Binocular Trifocality
Cataract Surgery
Spectacle Independence
Intermediate Vision
 Photopic Vision
Mesopic Vision
Scotopic Vision
Binocular Vision
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases