Back to resultsUse of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Primary Purpose
Cataract, Astigmatism
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Acrysof Toric one-piece intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Astigmatism, Cataract
Eligibility Criteria
Inclusion Criteria:
- Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.
Exclusion Criteria:
- Irregular astigmatism,
- Keratoconus,
- Previous Refractive Surgery.
Sites / Locations
- Asociacion Para Evitar la Ceguera en Mexico
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acrysof Toric intraocular lens
Arm Description
A One piece, acrylic intraocular lens is implanted in the lens bag.
Outcomes
Primary Outcome Measures
Neutralization of Astigmatism
Secondary Outcome Measures
Full Information
NCT ID
NCT00925886
First Posted
June 18, 2009
Last Updated
June 19, 2009
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT00925886
Brief Title
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Official Title
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism
Keywords
Astigmatism, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acrysof Toric intraocular lens
Arm Type
Experimental
Arm Description
A One piece, acrylic intraocular lens is implanted in the lens bag.
Intervention Type
Procedure
Intervention Name(s)
Acrysof Toric one-piece intraocular lens
Other Intervention Name(s)
Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC
Intervention Description
Cataract Surgery with a intraocular lens implantation
Primary Outcome Measure Information:
Title
Neutralization of Astigmatism
Time Frame
3 months after cataract surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.
Exclusion Criteria:
Irregular astigmatism,
Keratoconus,
Previous Refractive Surgery.
Facility Information:
Facility Name
Asociacion Para Evitar la Ceguera en Mexico
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
04030
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
18721707
Citation
Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
Results Reference
background
Learn more about this trial
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
We'll reach out to this number within 24 hrs