Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

This study has been completed.
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00925886
First received: June 18, 2009
Last updated: June 19, 2009
Last verified: June 2009
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 18, 2009
Last Updated: June 19, 2009
Health Authority: Mexico: National Institute of Public Health, Health Secretariat

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

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

ClinicalTrials.gov processed this record on April 17, 2014