Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

NCT ID: NCT00347243

Last Updated: 2006-10-26

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

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-06-30

Brief Summary

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Purpose:To compare visual performance, total and high order wavefront aberrations (coma, spherical aberration and other terms) and contrast sensitivity in eyes implanted with one monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO, Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)

Detailed Description

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Conditions

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Cataract Pseudophakia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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phacoemulsification (cataract surgery)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with bilateral visually significant senile cataract, corneal astigmatism less than 2.0 diopters and potential acuity meter (PAM) better than 0.2 LogMar

Exclusion Criteria

* any other ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, decentration (estimated by retro illumination and digital photo) greater than 0.4mm13 or loss of follow-up
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Paulo Schor, MD

Role: STUDY_DIRECTOR

UNIFESP - EPM

Locations

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Federal University of Sao paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Altmann GE. Wavefront-customized intraocular lenses. Curr Opin Ophthalmol. 2004 Aug;15(4):358-64. doi: 10.1097/00055735-200408000-00013.

Reference Type RESULT
PMID: 15232477 (View on PubMed)

Other Identifiers

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CEP012/06

Identifier Type: -

Identifier Source: org_study_id