ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

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.
ClinicalTrials.gov Identifier: NCT00925886
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

Brief Summary:
The purpose of this study is to evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens.

Condition or disease Intervention/treatment Phase
Cataract Astigmatism Procedure: Acrysof Toric one-piece intraocular lens Phase 4

Detailed Description:
Patients with Cataract are treated with phacoemulsification of the lens with an implantation of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an implantation of a toric intraocular lens.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Study Start Date : July 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acrysof Toric intraocular lens
A One piece, acrylic intraocular lens is implanted in the lens bag.
Procedure: Acrysof Toric one-piece intraocular lens
Cataract Surgery with a intraocular lens implantation
Other Name: Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC



Primary Outcome Measures :
  1. Neutralization of Astigmatism [ Time Frame: 3 months after cataract surgery ]


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:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.

Exclusion Criteria:

  • Irregular astigmatism,
  • Keratoconus,
  • Previous Refractive Surgery.

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): NCT00925886


Locations
Mexico
Asociacion Para Evitar la Ceguera en Mexico
Mexico City, D.f., Mexico, 04030
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México

Publications:
Responsible Party: Guadalupe Cervantes Coste, Asociación Para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT00925886     History of Changes
Other Study ID Numbers: 07-01
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009

Keywords provided by Asociación para Evitar la Ceguera en México:
Astigmatism
Cataract

Additional relevant MeSH terms:
Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors