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Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00925886
First Posted: June 22, 2009
Last Update Posted: June 22, 2009
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:
Asociación para Evitar la Ceguera en México
  Purpose
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 Intervention Phase
Cataract Astigmatism Procedure: Acrysof Toric one-piece intraocular lens Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

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

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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.
  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): 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
  More Information

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 Submitted: June 18, 2009
First Posted: June 22, 2009
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


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