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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01027533
First received: December 7, 2009
Last updated: July 1, 2010
Last verified: March 2009
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • reading speed and contrast sensitivity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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