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

NCT02633228 | Completed Phase 4

• 1 other identifier: EA2/129/14
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Multifocal Intraocular Lens; Binocular Trifocality; Cataract Surgery; Spectacle Independence; Intermediate Vision; Photopic Vision; Mesopic Vision; Scotopic Vision; Binocular Vision

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Spectacle independence in the far, intermediate and near

  3 months

Interventions

Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses DEVICE

Binocular implantation of the combination of Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D in the distance-dominant eye and +3.0 D in the fellow eye.

Also known as: Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D (LU-313 MF20T/LS-313 MF20) and +3.0 D (LU-313 MF30T/LS-313 MF30) are used.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr. med. Eckart Bertelmann: lead

Study Sites (1)

Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, 13353, Germany

Location

Related Publications (5)

• 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.

  PMID: 23557223 BACKGROUND

• 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.

  PMID: 26469073 BACKGROUND

• 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.

  PMID: 25884577 BACKGROUND

• 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.

  PMID: 22496436 BACKGROUND

• 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.

  PMID: 22373031 BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Eckart Bertelmann, MD, PhD

  Charité - University Medicine Berlin, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)