Clinical trial NCT02633228: Visual Acuity After the Combined Binocular Implantation of +2.0 Diopters and +3.0 Diopters Oculentis Multifocal Intraocular Lenses.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Multifocal Intraocular Lens
Binocular Trifocality
Cataract Surgery
Spectacle Independence
Intermediate Vision
Photopic Vision
Mesopic Vision
Scotopic Vision
Binocular Vision
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Visual acuities in the far, intermediate and near
timeFrame: 1 month
measure: Visual acuities in the far, intermediate and near
timeFrame: 3 months
measure: Mesopic vision
timeFrame: 1 month
measure: Mesopic vision
timeFrame: 3 months
measure: Scotopic contrast sensitivity
timeFrame: 1 month
measure: Scotopic contrast sensitivity
timeFrame: 3 months
Secondary outcomes:
measure: Spectacle independence in the far, intermediate and near
timeFrame: 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin, Department of Ophthalmology
Study officials:
affiliation: Charité - University Medicine Berlin, Department of Ophthalmology
name: Eckart Bertelmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alio JL, Plaza-Puche AB, Javaloy J, Ayala MJ, Vega-Estrada A. Clinical and optical intraocular performance of rotationally asymmetric multifocal IOL plate-haptic design versus C-loop haptic design. J Refract Surg. 2013 Apr;29(4):252-9. doi: 10.3928/1081597X-20130318-04.
citation: Bonaque-Gonzalez S, Rios S, Amigo A, Lopez-Gil N. Influence on Visual Quality of Intraoperative Orientation of Asymmetric Intraocular Lenses. J Refract Surg. 2015 Oct;31(10):651-7. doi: 10.3928/1081597X-20150922-01.
citation: Garcia-Domene MC, Felipe A, Peris-Martinez C, Navea A, Artigas JM, Pons AM. Image quality comparison of two multifocal IOLs: influence of the pupil. J Refract Surg. 2015 Apr;31(4):230-5. doi: 10.3928/1081597X-20150319-02.
citation: Alio JL, Plaza-Puche AB, Pinero DP. Rotationally asymmetric multifocal IOL implantation with and without capsular tension ring: refractive and visual outcomes and intraocular optical performance. J Refract Surg. 2012 Apr;28(4):253-8. doi: 10.3928/1081597X-20120314-01.
citation: Munoz G, Albarran-Diego C, Javaloy J, Sakla HF, Cervino A. Combining zonal refractive and diffractive aspheric multifocal intraocular lenses. J Refract Surg. 2012 Mar;28(3):174-81. doi: 10.3928/1081597X-20120215-02.