NCT00760487

Brief Summary

The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.7 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 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 7, 2010

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

Enrollment Period

1.7 years

First QC Date

September 25, 2008

Results QC Date

September 22, 2009

Last Update Submit

January 12, 2012

Conditions

Cataract

Keywords

Cataract AcrySof Toric IOLBilateral cataract

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity (VA)

    Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

    Pre-operative, 1 month, 3 month, and 6 month post-operative

Secondary Outcomes (2)

  • Spectacle Independence

    6 months post-operative

  • IOL Rotation

    6 months post-operative

Study Arms (1)

AcrySof Toric IOL

EXPERIMENTAL

AcrySof Toric Intraocular Lens (IOL)

Device: AcrySof Toric IOL

Interventions

AcrySof Toric IOLDEVICE

Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

AcrySof Toric IOL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Are a candidate for bilateral implantation
  • In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes
  • In need of spherical correction between 10.0 Diopter (D) and 30.0 D
  • Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry
  • Willing and able to complete all required postoperative visits
  • Able to comprehend and sign a statement of informed consent
  • Pupil dilation ≥ 6.0 mm
  • Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

You may not qualify if:

  • Previous cataract patient without potential of bilateral implantation
  • Females of child bearing potential
  • Irregular corneal astigmatism
  • Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana
  • Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
  • Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)
  • Clinically significant corneal dystrophy (including Fuch's dystrophy)
  • Previous corneal transplant
  • Amblyopia
  • Glaucoma (medically uncontrolled)
  • Clinically significant RPE/Macular changes
  • Proliferative diabetic retinopathy
  • History of macular edema
  • Previous history of retinal detachment
  • History of uveitis/iritis
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

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
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Last Updated

January 16, 2012

Results First Posted

April 7, 2010

Record last verified: 2012-01

Locations

US(1)