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

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ClinicalTrials.gov Identifier: NCT01027533
Recruitment Status : Completed
First Posted : December 8, 2009
Last Update Posted : July 2, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment
To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity 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
Estimated Enrollment : 32 participants
Time Perspective: Prospective
Study Start Date : December 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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




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

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


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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.

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