NCT00758550

Brief Summary

The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2010

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

1.2 years

First QC Date

September 23, 2008

Results QC Date

August 13, 2009

Last Update Submit

March 4, 2010

Conditions

Visual Function

Keywords

Visual function;Refractive cylinder;AcrySof® Toric;AcrySof® Natural

Outcome Measures

Primary Outcomes (1)

  • Uncorrected Visual Acuity (UCVA)

    Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

    6 Months after surgery

Secondary Outcomes (1)

  • Questionnaire Results

    6 Months

Study Arms (2)

AcrySof Toric IOL

EXPERIMENTAL

AcrySof Toric Intraocular Lens (IOL)

Device: AcrySof® Toric IOL

AcrySof Natural IOL

ACTIVE COMPARATOR

AcrySof Natural Intraocular Lens (IOL)

Device: AcrySof Natural

Interventions

AcrySof® Toric IOLDEVICE

AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

AcrySof Toric IOL
AcrySof NaturalDEVICE

AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

AcrySof Natural IOL

Eligibility Criteria

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

You may qualify if:

  • Bilateral cataracts
  • \~80 years of age
  • Days - 1 Week interval between a single patient's surgery
  • dilated pupil size (in dim light) ≥ 4.0 mm
  • Anticipated correction with an IOL of +10 Diopters \~ +25 Diopters
  • Diopters of astigmatism preoperatively as measured by Keratometry readings

You may not qualify if:

  • Preoperative ocular pathology
  • Previous intraocular or corneal surgery
  • An increased risk for complications which could require vitreoretinal surgery
  • Corneal irregularities
  • Corneal opacities
  • Current contact lens usage(within 6 months prior to first surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

Results Point of Contact

Title
Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937; 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

April 1, 2007

Primary Completion

June 1, 2008

Last Updated

March 16, 2010

Results First Posted

March 16, 2010

Record last verified: 2010-03

Locations

US(1)