- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347243
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses
October 25, 2006 updated by: Federal University of São Paulo
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Sao Paulo, SP, Brazil, 04044-020
- Federal University of São Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paulo Schor, MD, UNIFESP - EPM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
June 30, 2006
First Submitted That Met QC Criteria
June 30, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
October 26, 2006
Last Update Submitted That Met QC Criteria
October 25, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP012/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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