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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01027533
Enrollment
32
Registered
2009-12-08
Start date
2009-12-31
Completion date
2009-12-31
Last updated
2010-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

multifocal intraocular lens, visual acuity, presbiopia

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.

Interventions

OTHERImplantation of a multifocal Intraocular lens

Bilateral implantation of a multifocal IOl

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
distance,intermediate and near visual acuity1, 3 and 6 months

Secondary

MeasureTime frame
reading speed and contrast sensitivity6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026