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

NCT02314572 | Completed Phase 4

• 1 other identifier: EA1/124/13
• 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 +2.5 D and +3.0 D apodized diffractive 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

Study Arms (1)

Single-arm

OTHER

Device: Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses

Interventions

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

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.

Also known as: AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D (SV25-type) and +3.0 D (SN6A-type) are used.

Single-arm

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

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - University Medicine Berlin, Department of Ophthalmology

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (6)

• Pedrotti E, Mastropasqua R, Passilongo M, Parisi G, Marchesoni I, Marchini G. Comparison of two multifocal intraocular lens designs that differ only in near add. J Refract Surg. 2014 Nov;30(11):754-60. doi: 10.3928/1081597X-20141021-07.

  PMID: 25375848 BACKGROUND

• Alfonso JF, Knorz M, Fernandez-Vega L, Rincon JL, Suarez E, Titke C, Kohnen T. Clinical outcomes after bilateral implantation of an apodized +3.0 D toric diffractive multifocal intraocular lens. J Cataract Refract Surg. 2014 Jan;40(1):51-9. doi: 10.1016/j.jcrs.2013.06.026.

  PMID: 24355720 BACKGROUND

• Javitt JC, Steinert RF. Cataract extraction with multifocal intraocular lens implantation: a multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes. Ophthalmology. 2000 Nov;107(11):2040-8. doi: 10.1016/s0161-6420(00)00368-7.

  PMID: 11054329 BACKGROUND

• Vingolo EM, Grenga P, Iacobelli L, Grenga R. Visual acuity and contrast sensitivity: AcrySof ReSTOR apodized diffractive versus AcrySof SA60AT monofocal intraocular lenses. J Cataract Refract Surg. 2007 Jul;33(7):1244-7. doi: 10.1016/j.jcrs.2007.03.052.

  PMID: 17586381 BACKGROUND

• Cillino G, Casuccio A, Pasti M, Bono V, Mencucci R, Cillino S. Working-age cataract patients: visual results, reading performance, and quality of life with three diffractive multifocal intraocular lenses. Ophthalmology. 2014 Jan;121(1):34-44. doi: 10.1016/j.ophtha.2013.06.034. Epub 2013 Aug 14.

  PMID: 23953097 BACKGROUND

• Chiam PJ, Chan JH, Aggarwal RK, Kasaby S. ReSTOR intraocular lens implantation in cataract surgery: quality of vision. J Cataract Refract Surg. 2006 Sep;32(9):1459-63. doi: 10.1016/j.jcrs.2006.04.015.

  PMID: 16931256 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

  eckart.bertelmann@charite.de

  PRINCIPAL INVESTIGATOR

• Tobias Brockmann, MD

  tobias.brockmann@charite.de

  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: PRINCIPAL INVESTIGATOR
• PI Title: managing senior physician

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 11, 2014
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

DE (1)