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

Cataract Clinical Trial

Official title:

A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225926
• Other study ID #: M10-003
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: September 24, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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;

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Toric T3 - T9
Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient
• IQ SN60WF
Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No