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
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, see Learn About Clinical Studies.

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 August 01, 2014