Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism
Sponsor
Asociación para Evitar la Ceguera en México (Other)
Overall Status
Completed
CT.gov ID
NCT00925886
Collaborator
(none)
50
1
1
20
2.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Interventional
Actual Enrollment
:
50 participants
Allocation:
N/A
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
:
Jul 1, 2007
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Neutralization of Astigmatism [3 months after cataract surgery]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.
Exclusion Criteria:
-
Irregular astigmatism,
-
Keratoconus,
-
Previous Refractive Surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asociacion Para Evitar la Ceguera en Mexico | Mexico City | D.f. | Mexico | 04030 |
Sponsors and Collaborators
- Asociación para Evitar la Ceguera en México
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00925886
Other Study ID Numbers:
- 07-01
First Posted:
Jun 22, 2009
Last Update Posted:
Jun 22, 2009
Last Verified:
Jun 1, 2009