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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Binocular cataract surgery with phacoemulsification and implantation of 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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité - University Medicine Berlin, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuities in the far, intermediate and near	Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).	1 month
Visual acuities in the far, intermediate and near	Visual acuities are tested under photopic conditions at 5 m, intermediate (80 cm) and patient-preferred near distance (≈ 40 cm).	3 months
Mesopic vision	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.	1 month
Mesopic vision	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.	3 months
Scotopic contrast sensitivity	Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.	1 month
Scotopic contrast sensitivity	Scotopic contrast sensitivity are tested at 0.1 cd/m2, 0.032 cd/m2 and 0.1 cd/m2 with glare.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectacle independence in the far, intermediate and near	Spectacle independence as stated by the patient.	3 months

Collaborators and Investigators

• Sponsor: PD Dr. med. Eckart Bertelmann
• Investigators: Principal Investigator: Eckart Bertelmann, MD, PhD, Charité - University Medicine Berlin, Department of Ophthalmology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Cataract Surgery; Multifocal Intraocular Lens; Binocular Trifocality; Spectacle Independence; Intermediate Vision; Photopic Vision; Mesopic Vision; Scotopic Vision; Binocular Vision
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EA2/129/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No