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

• Sponsor: Alcon Research (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00929747
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: Toric; Procedure: Limbal Relaxing Incision	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Toric IOL AcrySof IQ Toric IOL	Device: Toric; Unilateral implantation of the AcrySof IQ Toric IOL
Active Comparator: Limbal Relaxing Incision AcrySof IQ with Limbal Relaxing Incision	Procedure: Limbal Relaxing Incision; Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery

Outcome Measures

Primary Outcome Measures

1. Corneal aberration [3 months]

Secondary Outcome Measures

1. Visual acuity [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

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: NCT00929747
• Other Study ID Numbers: M08-008
• First Posted: Jun 29, 2009
• Last Update Posted: Apr 12, 2012
• Last Verified: Oct 1, 2009

• Keywords provided by Alcon Research: Cataract; Toric; IOL; AcrySof, LRI
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Apr 12, 2012