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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01027533
First Posted: December 8, 2009
Last Update Posted: July 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • distance,intermediate and near visual acuity [ Time Frame: 1, 3 and 6 months ]

Secondary Outcome Measures:
  • reading speed and contrast sensitivity [ Time Frame: 6 months ]

Estimated Enrollment: 32
Study Start Date: December 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The sutdy population will be patients implanted bilaterally with the selected multifocal IOL
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01027533


Locations
Brazil
University of São Paulo
São Paulo, SP, Brazil, 054000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Marcony Santhiago, MD University of São Paulo