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

This study has been withdrawn prior to enrollment.
(Management Decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00929747
First received: June 25, 2009
Last updated: April 10, 2012
Last verified: October 2009
History of Changes
  Purpose

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 Intervention Phase
Cataracts
 Device: Toric
Procedure: Limbal Relaxing Incision
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Corneal aberration [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929747

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00929747     History of Changes
Other Study ID Numbers: M08-008
Study First Received: June 25, 2009
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Cataract
Toric
IOL
AcrySof, LRI

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013