Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

This study has been completed.

Sponsored by:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00347243

Purpose

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)

Condition	Intervention	Phase
Cataract Pseudophakia	Procedure: phacoemulsification (cataract surgery)	Phase IV

MedlinePlus related topics: Cataract

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical

Further study details as provided by Federal University of São Paulo:

Study Start Date:	September 2005
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347243

Locations

Brazil, SP
Federal University of Sao paulo
Sao Paulo, SP, Brazil, 04044-020

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Study Director:

Paulo Schor, MD

UNIFESP - EPM

More Information

Publications of Results:

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

Study ID Numbers:	CEP012/06
Study First Received:	June 30, 2006
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00347243
Health Authority:	Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

Signs and Symptoms
Pseudophakia
Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on January 14, 2009