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

Phase 4

Withdrawn

• Conditions: Cataract
• Interventions: Device: Akreos® MI60 intraocular lens; Device: AcrySof® IQ IOL; Device: Tecnis® Aspheric intraocular lens

• Registration Number: NCT00760058
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Status Verified: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Akreos® MI60 intraocular lens	Akreos® MI60 intraocular lens
1	AcrySof® IQ IOL	AcrySof® IQ intraocular lens
2	Tecnis® Aspheric intraocular lens	Tecnis® Aspheric intraocular lens

Primary Outcome Measures

Name	Time	Method
Contrast sensitivity	3 months

Secondary Outcome Measures

Name	Time	Method
Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.	3 months

Trial Locations

Locations (1)

Alcon Call Center; 🇺🇸 Fort Worth, Texas, United States