Visual Function After Implantation of AcrySof® Toric Lens

Cataract Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01074606
• Other study ID #: MT-0902
• Status: Terminated
• Phase: Phase 4
• First received: February 23, 2010
• Last updated: September 18, 2012
• Start date: January 2010

Study information

• Verified date: August 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review BoardTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof Toric Intraocular Lens
Implantation of the AcrySof Toric Intraocular Lens (IOL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Refractive Cylinder		Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative	No
Secondary	Uncorrected distance visual acuity (UCDVA)		Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative	No
Secondary	Best corrected distance visual acuity (BDCVA)		Pre-operative, 1 month postoperative, 3 months postoperative	No