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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Pseudophakia
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014