Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

This study has been completed.

Sponsor:

Information provided by:

Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT00347243

First received: June 30, 2006

Last updated: October 25, 2006

Last verified: March 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

June 30, 2006

Last Updated Date

October 25, 2006

Start Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00347243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

Official Title ^ICMJE

Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Cataract
Pseudophakia

Intervention ^ICMJE

Procedure: phacoemulsification (cataract surgery)

Study Arm (s)

Not Provided

Publications *

Altmann GE. Wavefront-customized intraocular lenses. Curr Opin Ophthalmol. 2004 Aug;15(4):358-64. Review.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00347243

Other Study ID Numbers ^ICMJE

CEP012/06

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Federal University of São Paulo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Paulo Schor, MD

UNIFESP - EPM

Information Provided By

Federal University of São Paulo

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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