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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014