Visual Function After Implantation of AcrySof® Toric Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01074606
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arm: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof Toric Intraocular Lens	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Mar 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Postoperative Refractive Cylinder [Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative]

Secondary Outcome Measures

1. Uncorrected distance visual acuity (UCDVA) [Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative]

2. Best corrected distance visual acuity (BDCVA) [Pre-operative, 1 month postoperative, 3 months postoperative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Changhua City		Taiwan	500

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01074606
• Other Study ID Numbers: MT-0902
• First Posted: Feb 24, 2010
• Last Update Posted: Sep 19, 2012
• Last Verified: Aug 1, 2011

• Keywords provided by Alcon Research: Cataract
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Sep 19, 2012