A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

NCT01225926 | Completed Results

• 1 other identifier: M10-003
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.

Conditions

Cataract

Keywords

Intraocular Lens; Toric

Outcome Measures

Primary Outcomes (1)

• Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3

  Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.

  Month 3

Study Arms (2)

Toric T3 - T9

EXPERIMENTAL

AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.

Device: Toric T3 - T9

IQ SN60WF

ACTIVE COMPARATOR

AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.

Device: IQ SN60WF

Interventions

Toric T3 - T9 DEVICE

Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient

Also known as: AcrySof® IQ Toric IOL Models SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, or SN6AT9

Toric T3 - T9

IQ SN60WF DEVICE

Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient

Also known as: AcrySof® IQ IOL Model SN60WF

IQ SN60WF

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to understand and sign an informed consent;
• Willing and able to attend post-operative examinations per protocol schedule;
• In good ocular health, with the exception of cataracts;
• Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
• Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
• In good ocular health, with the exception of cataracts;
• Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;

You may not qualify if:

• Previous corneal surgery;
• Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Ocular disease and/or condition that may compromise study results;
• Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
• Pregnant or planning pregnancy during course of study;
• Participation in any other investigational study within 30 days prior to enrolment;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

This study was considered a pilot study and did not have an expectation to meet any of the study endpoints.

Results Point of Contact

• Title: Manoj Venkiteshwar, Brand Lead, Global Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 21, 2010
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 29, 2013
• Results First Posted: September 24, 2013

Record last verified: 2013-09