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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract | Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses | Phase 4 |
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 |
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. |
- 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).
- 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).
- Mesopic vision [ Time Frame: 1 month ]Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
- Mesopic vision [ Time Frame: 3 months ]Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.
- 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.
- 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.
- Spectacle independence in the far, intermediate and near [ Time Frame: 3 months ]Spectacle independence as stated by the patient.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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
Germany | |
Charité - University Medicine Berlin, Department of Ophthalmology | |
Berlin, Germany, 13353 |
Principal Investigator: | Eckart Bertelmann, MD, PhD | eckart.bertelmann@charite.de | |
Principal Investigator: | Tobias Brockmann, MD | tobias.brockmann@charite.de |
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 |
Multifocal Intraocular Lens Binocular Trifocality Cataract Surgery Spectacle Independence Intermediate Vision |
Photopic Vision Mesopic Vision Scotopic Vision Binocular Vision |
Cataract Lens Diseases Eye Diseases |