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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This study has been withdrawn prior to enrollment.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:

ClinicalTrials.gov Identifier:

NCT00929747

First Posted: June 29, 2009

Last Update Posted: April 12, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Alcon Research

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 (Participant) 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 ]

Secondary Outcome Measures:

Visual acuity [ Time Frame: 3 months ]


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Contacts and Locations

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


United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00929747 History of Changes
Other Study ID Numbers:	M08-008
First Submitted:	June 25, 2009
First Posted:	June 29, 2009
Last Update Posted:	April 12, 2012
Last Verified:	October 2009

Keywords provided by Alcon Research:


Cataract Toric IOL AcrySof, LRI

Additional relevant MeSH terms:


Cataract Lens Diseases Eye Diseases

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