NCT00878839

Brief Summary

A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
Same day 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
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
Last Updated

August 2, 2012

Status Verified

June 1, 2012

Enrollment Period

Same day

First QC Date

April 7, 2009

Last Update Submit

July 31, 2012

Conditions

CataractsAstigmatism

Keywords

CataractToric IOLCorneal AberrationAstigmatismAcrySof

Outcome Measures

Primary Outcomes (1)

  • Corneal Aberration

    3 months

Secondary Outcomes (1)

  • Visual acuity, residual refractive cylinder, lens alignment

    3 months

Study Arms (1)

Toric

OTHER

AcrySof Toric IOL to assess corneal aberration

Device: Toric

Interventions

ToricDEVICE

AcrySof Toric IOL

Toric

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Operable cataracts;
  • Good ocular health;
  • Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)

You may not qualify if:

  • \>2.06 D astigmatism at corneal plane;
  • irregular astigmatism;
  • prior or ongoing corneal disease or scarring;
  • history of ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 9, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 2, 2012

Record last verified: 2012-06