NCT00925886

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

June 18, 2009

Last Update Submit

May 31, 2024

Conditions

CataractAstigmatism

Keywords

AstigmatismCataract

Outcome Measures

Primary Outcomes (1)

  • Neutralization of Astigmatism

    3 months after cataract surgery

Study Arms (1)

Acrysof Toric intraocular lens

EXPERIMENTAL

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

Procedure: Acrysof Toric one-piece intraocular lens

Interventions

Acrysof Toric one-piece intraocular lensPROCEDURE

Cataract Surgery with a intraocular lens implantation

Also known as: Acrysof Single Piece Natural Toric Lens. ALCON LABORATORIES INC
Acrysof Toric intraocular lens

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.

You may not qualify if:

  • Irregular astigmatism,
  • Keratoconus,
  • Previous Refractive Surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Para Evitar la Ceguera en Mexico

Mexico City, D.F., 04030, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 18721707BACKGROUND

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 22, 2009

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

ME(1)