Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Cataract Clinical Trial

Official title:

Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00760058
• Other study ID #: AUS-06-02
• Status: Withdrawn
• Phase: Phase 4
• First received: September 24, 2008
• Last updated: May 8, 2015
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia:Health Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects, aged 50 and over.

• Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.

• Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.

• Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.

• Subjects' pupil size must be = 4.5 mm in mesopic conditions.

Exclusion Criteria:

• Subjects who have previously had corneal surgery.

• Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology

• Subjects with corneal pathology.

• Subjects with astigmatism of greater than 1D.

• Subjects diagnosed with glaucoma.

• Subjects diagnosed with diabetes.

• Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment

• Subjects with a know history of poor compliance

• Subjects with planned adjunctive surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• AcrySof® IQ IOL
Replacement of natural crystalline lens in cataract surgery
• Tecnis® Aspheric intraocular lens
Replacement of natural crystalline lens in cataract surgery
• Akreos® MI60 intraocular lens
Replacement of natural crystalline lens in cataract surgery

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast sensitivity		3 months	No
Secondary	Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.		3 months	No