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

Cataracts Clinical Trial

Official title:

An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190631
• Other study ID #: M-10-008
• Status: Completed
• Phase: N/A
• First received: August 26, 2010
• Last updated: November 27, 2012
• Start date: July 2010

Study information

• Verified date: November 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataracts

Intervention

Device:
• Acrysof IQ (SN60WF) IOL
Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast Sensitivity	Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.	Day 90 postoperative	No
Secondary	Total Higher Order Aberrations	A higher order aberration is a distortion acquired by a wavefront light when it passes through an eye with irregularities of its refractive components (tear film, cornea, aqueous humor, crystalline lens and vitreous humor). It is measured via wavefront measurements according to manufacturer's instructions with a LADARWave (Alcon Laboratories, Inc., Ft. Worth TX).	Day 90 postoperative	No
Secondary	Corneal Spherical Aberration	Corneal spherical aberration is the blurring of an image that occurs when light from the margin of a lens or mirror with a spherical surface comes to a shorter focus than light from the central portion. The changing focal length is caused by deviations in the lens or mirror surface from a true sphere and is measured by corneal topography with a commercially available topographer in accordance with manufacturer's guidelines.	Day 90 postoperative	No
Secondary	Uncorrected Visual Acuity (UCVA)	Uncorrected visual acuity, i.e., visual acuity without any type of corrective lenses, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.	Day 90 postoperative	No
Secondary	Best Corrected Visual Acuity (BCVA)	Best corrected visual acuity, i.e., visual correction utilizing a phoropter or trial frames, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.	Day 90 postoperative	No
Secondary	Low Contrast (10%) Visual Acuity	Visual acuity is tested using 10% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts under photopic conditions. Testing is performed using the correction from the manifest refraction at a distance calibrated for the chart. Visual acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.	Day 90 postoperative	No
Secondary	Quality of Vision Questionnaire	As completed by the participant.	Day 90 postoperative	No