Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)

Astigmatism Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00878839
• Other study ID #: M09-016
• Status: Withdrawn
• Phase: N/A
• First received: April 7, 2009
• Last updated: July 31, 2012
• Start date: March 2009
• Est. completion date: March 2009

Study information

• Verified date: June 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Operable cataracts;

• Good ocular health;

• Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)

Exclusion Criteria:

• >2.06 D astigmatism at corneal plane;

• irregular astigmatism;

• prior or ongoing corneal disease or scarring;

• history of ocular disease

Study Design

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

Related Conditions & MeSH terms

• Astigmatism
• Cataracts

Intervention

Device:
• Toric
AcrySof Toric IOL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Aberration		3 months	No
Secondary	Visual acuity, residual refractive cylinder, lens alignment		3 months	No