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

Primary Purpose

Cataracts

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Toric
Limbal Relaxing Incision
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Cataract, Toric, IOL, AcrySof, LRI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Toric IOL

Limbal Relaxing Incision

Arm Description

AcrySof IQ Toric IOL

AcrySof IQ with Limbal Relaxing Incision

Outcomes

Primary Outcome Measures

Corneal aberration

Secondary Outcome Measures

Visual acuity

Full Information

First Posted
June 25, 2009
Last Updated
April 10, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00929747
Brief Title
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients
Official Title
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Management Decision
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataract, Toric, IOL, AcrySof, LRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toric IOL
Arm Type
Active Comparator
Arm Description
AcrySof IQ Toric IOL
Arm Title
Limbal Relaxing Incision
Arm Type
Active Comparator
Arm Description
AcrySof IQ with Limbal Relaxing Incision
Intervention Type
Device
Intervention Name(s)
Toric
Intervention Description
Unilateral implantation of the AcrySof IQ Toric IOL
Intervention Type
Procedure
Intervention Name(s)
Limbal Relaxing Incision
Intervention Description
Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery
Primary Outcome Measure Information:
Title
Corneal aberration
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: operable cataracts good ocular health 0.5 D to 2.0 D of corneal astigmatism Exclusion Criteria: > 2.0 D astigmatism irregular astigmatism prior or ongoing corneal disease or scarring history of ocular disease
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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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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