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

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ClinicalTrials.gov Identifier: NCT00929747
Recruitment Status : Withdrawn (Management Decision)
First Posted : June 29, 2009
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : June 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Corneal aberration [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929747


Locations
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United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00929747    
Other Study ID Numbers: M08-008
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: October 2009
Keywords provided by Alcon Research:
Cataract
Toric
IOL
AcrySof, LRI
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases