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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314572
• Other study ID #: EA1/124/13
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2014
• Last updated: December 15, 2015
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin, Department of Ophthalmology	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Alfonso JF, Knorz M, Fernandez-Vega L, Rincón 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. — View Citation

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. Erratum in: J Cataract Refract Surg. 2006 Dec;32(12):1987. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Mesopic vision	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.	1 month	No
Primary	Mesopic vision	Mesopic visual acuities are tested under high-contrast, low-contrast and low-contrast with glare.	3 months	No
Primary	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	No
Primary	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	No
Secondary	Spectacle independence in the far, intermediate and near	Spectacle independence as stated by the patient.	3 months	No