NCT00825513

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Akreos Toric IOL following cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2009

Longer than 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

3.1 years

First QC Date

January 16, 2009

Last Update Submit

March 19, 2013

Conditions

CataractAstigmatism

Outcome Measures

Primary Outcomes (1)

  • Reduction of cylinder, Lens axis misalignment as determined by a photographic method.

    32 months

Secondary Outcomes (1)

  • Lens misalignment as determined by postoperative manifest refraction and vector analysis.

    32 months

Study Arms (2)

Akreos Toric

EXPERIMENTAL

Akreos Toric Intraocular Lens

Device: Akreos Toric IOL

Akreos Advanced

ACTIVE COMPARATOR

Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Device: Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)

Interventions

Akreos Toric IOLDEVICE

Lens implant following cataract surgery

Akreos Toric
Akreos Advanced Optics Aspheric Intraocular Lens (Akreos AO)DEVICE

Lens implant following cataract surgery

Akreos Advanced

Eligibility Criteria

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

You may qualify if:

  • Subjects must be willing and able to provide written consent on the EC approved Informed Consent form.
  • Subjects must require a lens power from 15 to 30 diopters.

You may not qualify if:

  • Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
  • Subjects with corneal pathology potentially affecting topography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Clinical Sciences/ Ophthalmology Umea University Hospital

Umeå, SE-901 85, Sweden

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Gabriele Brenger

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

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

January 16, 2009

First Posted

January 21, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations

SE(1)