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NCT00347243 Clinical Trial

Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses

Cataract Clinical Trial

Official title:
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00347243
Other study ID # CEP012/06
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2006
Last updated October 25, 2006
Start date September 2005
Est. completion date June 2006

Study information
Verified date March 2006
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 80 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• phacoemulsification (cataract surgery)

Locations
Country Name City State
Brazil Federal University of Sao paulo Sao Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

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