Rotational Stability of the AcrySof® Toric

Cataract Clinical Trial

Official title:

Rotational Stability of the AcrySof® Toric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762216
• Other study ID #: RM-08-001
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: October 26, 2012
• Start date: May 2008

Study information

• Verified date: May 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Monolateral or bilateral cataracts

• anticipated intraocular lens (IOL) power of +10 Diopters (D) ~ +25D

• 0.75 ~ 2.0 D of astigmatism measured preoperatively by Keratometry readings

• able to sign the informed consent, to comply with scheduled visits and other study procedures

Exclusion Criteria:

• Preoperative ocular pathology

• previous intraocular or corneal surgery

• an increased risk for complications which could require vitreoretinal surgery

• corneal irregularities

• corneal opacities

• current contact lens usage

• uncontrolled diabetes

Study Design

Allocation: Randomized, 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) into the eye following cataract extraction surgery

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rotational Stability	Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.	6 Months post-surgery	Yes
Secondary	Residual Refractive Cylinder	The refractive astigmatism 6 months post-surgery, measured in diopters.	6 Months post-surgery	Yes