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NCT00929747 Clinical Trial

Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients

Cataracts Clinical Trial

Official title:
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00929747
Other study ID # M08-008
Secondary ID
Status Withdrawn
Phase Phase 4
First received June 25, 2009
Last updated April 10, 2012
Start date June 2009
Est. completion date October 2009

Study information
Verified date October 2009
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. operable cataracts

2. good ocular health

3. 0.5 D to 2.0 D of corneal astigmatism

Exclusion Criteria:

1. > 2.0 D astigmatism

2. irregular astigmatism

3. prior or ongoing corneal disease or scarring

4. history of ocular disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Toric
Unilateral implantation of the AcrySof IQ Toric IOL
Procedure:
• Limbal Relaxing Incision
Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery

Locations
Country Name City State
United States Alcon Call Center for Trial Locations 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 Corneal aberration 3 months No
Secondary Visual acuity 3 months No
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