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

Completed

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

• Registration Number: NCT01027533
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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 Timeline

• Status Verified: 2009-03
• Study Start: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-08
• Last Update Submitted: 2010-07-01
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Restor +3	Implantation of a multifocal Intraocular lens	patients will be implanted bilaterally with Restor + 3
restor +4	Implantation of a multifocal Intraocular lens	Patients will be implanted bilaterally with Restor +4

Primary Outcome Measures

Name	Time	Method
distance,intermediate and near visual acuity	1, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
reading speed and contrast sensitivity	6 months

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, SP, Brazil