Status:
COMPLETED
An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation
Lead Sponsor:
Alcon Research
Conditions:
Cataracts
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of this study was to evaluate total residual spherical aberration (TSA) post-IOL implantation, and to determine if an association exists between TSA, postoperative high order aberrations (...
Detailed Description
Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.
Eligibility Criteria
Inclusion
- Age-related cataract grade 3 or lower in at least one eye;
- Planned cataract removal via phacoemulsification with an implantation of an aspheric IOL;
- Able to have an operation within 30 days of preoperative evaluation;
- Good ocular health, with the exception of cataracts;
- ≤ 1.50 diopter (D) of preoperative astigmatism by keratometry;
- Willing and able to understand and sign an informed consent;
- Willing and able to attend postoperative examinations per protocol schedule;
- Able to achieve 6.5mm dilated pupil;
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Preoperative ocular pathology as specified in protocol;
- Preoperative corneal pathology as specified in protocol;
- Keratometric astigmatism exceeding 1.50 diopter;
- Planned postoperative refraction for mono-vision;
- Uncontrolled diabetes;
- Use of any systemic or topical drug known to interfere with visual performance;
- Contact lens use during the active treatment portion of the trial;
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis;
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results;
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial;
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye;
- Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control;
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01190631
Start Date
July 1 2010
Last Update
November 29 2012
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134