Back to resultsWavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses
Primary Purpose
Cataract, Pseudophakia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
phacoemulsification (cataract surgery)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility 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
Sites / Locations
- Federal University of Sao paulo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00347243
First Posted
June 30, 2006
Last Updated
October 25, 2006
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00347243
Brief Title
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses
Official Title
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Pseudophakia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification (cataract surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Schor, MD
Organizational Affiliation
UNIFESP - EPM
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Sao paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04044-020
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15232477
Citation
Altmann GE. Wavefront-customized intraocular lenses. Curr Opin Ophthalmol. 2004 Aug;15(4):358-64. doi: 10.1097/00055735-200408000-00013.
Results Reference
result
Learn more about this trial
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses
We'll reach out to this number within 24 hrs