Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three

The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.

Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.

Study Overview

• Status: Completed
• Conditions: To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity
• Intervention / Treatment: Other: Implantation of a multifocal Intraocular lens

Detailed Description

Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.

Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.

• Study Type: Observational
• Enrollment (Anticipated): 32

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 054000
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The sutdy population will be patients implanted bilaterally with the selected multifocal IOL

Description

Inclusion Criteria:

• •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)

Exclusion Criteria:

• Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
• Surgical complications
• Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
• Incomplete follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Restor +3; patients will be implanted bilaterally with Restor + 3	Other: Implantation of a multifocal Intraocular lens; Bilateral implantation of a multifocal IOl; Other Names: Restor + 3 SN6AD1; Restor + 4 SN6AD3
restor +4; Patients will be implanted bilaterally with Restor +4	Other: Implantation of a multifocal Intraocular lens; Bilateral implantation of a multifocal IOl; Other Names: Restor + 3 SN6AD1; Restor + 4 SN6AD3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
distance,intermediate and near visual acuity	1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
reading speed and contrast sensitivity	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Marcony Santhiago, MD, University of Sao Paulo

Publications and helpful links

General Publications

• Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026.
• Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013.
• Alfonso JF, Fernandez-Vega L, Amhaz H, Montes-Mico R, Valcarcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014.
• Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 7, 2009
• First Posted (Estimate): December 8, 2009

Study Record Updates

• Last Update Posted (Estimate): July 2, 2010
• Last Update Submitted That Met QC Criteria: July 1, 2010
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: multifocal intraocular lens; visual acuity; presbiopia
• Other Study ID Numbers: MRS.1703