An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation

Alcon

Status

Completed

Conditions

Cataracts

Treatments

Device: Acrysof IQ (SN60WF) IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01190631

M-10-008

Details and patient eligibility

About

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 (HOA), and functional vision following IOL implantation in patients grouped by pre-operative corneal spherical aberration (CSA).

Full description

Patients will be grouped by pre-operative corneal spherical aberration (CSA) measures, i.e., ≤0.230 micron and ≥0.270 micron.

Enrollment

100 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.