NCT00929747

Brief Summary

A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

June 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

April 12, 2012

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

June 25, 2009

Last Update Submit

April 10, 2012

Conditions

Cataracts

Keywords

CataractToricIOLAcrySof, LRI

Outcome Measures

Primary Outcomes (1)

  • Corneal aberration

    3 months

Secondary Outcomes (1)

  • Visual acuity

    3 months

Study Arms (2)

Toric IOL

ACTIVE COMPARATOR

AcrySof IQ Toric IOL

Device: Toric

Limbal Relaxing Incision

ACTIVE COMPARATOR

AcrySof IQ with Limbal Relaxing Incision

Procedure: Limbal Relaxing Incision

Interventions

ToricDEVICE

Unilateral implantation of the AcrySof IQ Toric IOL

Toric IOL
Limbal Relaxing IncisionPROCEDURE

Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery

Limbal Relaxing Incision

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
  • D to 2.0 D of corneal astigmatism

You may not qualify if:

  • \> 2.0 D astigmatism
  • irregular astigmatism
  • prior or ongoing corneal disease or scarring
  • history of ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 29, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

April 12, 2012

Record last verified: 2009-10

Locations

US(1)