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

U

University of Sao Paulo

Status

Completed

Conditions

To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity

Treatments

Other: Implantation of a multifocal Intraocular lens

Study type

Observational

Funder types

Other

Identifiers

NCT01027533
MRS.1703

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

32 participants in 2 patient groups

Restor +3
Description:
patients will be implanted bilaterally with Restor + 3
Treatment:
Other: Implantation of a multifocal Intraocular lens
restor +4
Description:
Patients will be implanted bilaterally with Restor +4
Treatment:
Other: Implantation of a multifocal Intraocular lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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