Visual Function After Implantation of AcrySof® Toric Lens

September 18, 2012 updated by: Alcon Research
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua City, Taiwan, 500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
  • Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
  • All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
  • For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.

Exclusion Criteria:

  • Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
  • AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toric
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof Toric Intraocular Lens
Implantation of the AcrySof Toric Intraocular Lens (IOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative Refractive Cylinder
Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Uncorrected distance visual acuity (UCDVA)
Time Frame: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
Best corrected distance visual acuity (BDCVA)
Time Frame: Pre-operative, 1 month postoperative, 3 months postoperative
Pre-operative, 1 month postoperative, 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-0902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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