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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02314572
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
27
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
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 :
Mar 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: 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 Names:
  • 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

    Primary Outcome Measures

    1. 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).

    2. Visual acuities in the far, intermediate and near [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 [1 month]

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

    4. Mesopic vision [3 months]

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

    5. 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.

    6. Scotopic contrast sensitivity [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 [3 months]

      Spectacle independence as stated by the patient.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Charité - University Medicine Berlin, Department of Ophthalmology Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Principal Investigator: Eckart Bertelmann, MD, PhD, eckart.bertelmann@charite.de
    • Principal Investigator: Tobias Brockmann, MD, tobias.brockmann@charite.de

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Dec 11, 2014
    Last Update Posted:
    Dec 16, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by PD Dr. med. Eckart Bertelmann, managing senior physician, 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:
    Cataract

    Study Results

    No Results Posted as of Dec 16, 2015