DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Toric T3 - T9 (Device); IQ SN60WF (Device)

Phase: N/A

Status: Completed

Sponsored by: Alcon Research

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.

Clinical Details

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

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

Primary outcome: Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: March 2011
Last updated: September 24, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017