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

NCT ID: NCT01027533

Last Updated: 2010-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Restor +3

patients will be implanted bilaterally with Restor + 3

Implantation of a multifocal Intraocular lens

Intervention Type OTHER

Bilateral implantation of a multifocal IOl

restor +4

Patients will be implanted bilaterally with Restor +4

Implantation of a multifocal Intraocular lens

Intervention Type OTHER

Bilateral implantation of a multifocal IOl

Interventions

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Implantation of a multifocal Intraocular lens

Bilateral implantation of a multifocal IOl

Intervention Type OTHER

Other Intervention Names

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Restor + 3 SN6AD1 Restor + 4 SN6AD3

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo

Principal Investigators

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Marcony Santhiago, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026.

Reference Type BACKGROUND
PMID: 19631128 (View on PubMed)

Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013.

Reference Type BACKGROUND
PMID: 19545814 (View on PubMed)

Alfonso JF, Fernandez-Vega L, Amhaz H, Montes-Mico R, Valcarcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014.

Reference Type BACKGROUND
PMID: 19393889 (View on PubMed)

Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18.

Reference Type BACKGROUND
PMID: 19152978 (View on PubMed)

Other Identifiers

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MRS.1703

Identifier Type: -

Identifier Source: org_study_id

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