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

Alcon

Status: Completed

Conditions: Cataract

Treatments: Device: Toric T3 - T9; Device: IQ SN60WF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225926

M10-003

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

Toric T3 - T9

Experimental group

Description:

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.

Treatment:

Device: Toric T3 - T9

IQ SN60WF

Active Comparator group

Description:

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.

Treatment:

Device: IQ SN60WF