Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

NCT ID: NCT00925886

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Cataract Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acrysof Toric intraocular lens

A One piece, acrylic intraocular lens is implanted in the lens bag.

Group Type EXPERIMENTAL

Acrysof Toric one-piece intraocular lens

Intervention Type PROCEDURE

Cataract Surgery with a intraocular lens implantation

Interventions

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Acrysof Toric one-piece intraocular lens

Cataract Surgery with a intraocular lens implantation

Intervention Type PROCEDURE

Other Intervention Names

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Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC

Eligibility Criteria

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Inclusion Criteria

* Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.

Exclusion Criteria

* Irregular astigmatism,
* Keratoconus,
* Previous Refractive Surgery.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asociacion Para Evitar la Ceguera en Mexico

Mexico City, D.F., Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 18721707 (View on PubMed)

Other Identifiers

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07-01

Identifier Type: -

Identifier Source: org_study_id

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