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

Alcon

Status and phase: Withdrawn; Phase 4

Conditions: Cataract

Treatments: Device: AcrySof® IQ IOL; Device: Akreos® MI60 intraocular lens; Device: Tecnis® Aspheric intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00760058

AUS-06-02

Details and patient eligibility

About

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

1

Experimental group

Description:

AcrySof® IQ intraocular lens

Treatment:

Device: AcrySof® IQ IOL

2

Active Comparator group

Description:

Tecnis® Aspheric intraocular lens

Treatment:

Device: Tecnis® Aspheric intraocular lens

3

Active Comparator group

Description:

Akreos® MI60 intraocular lens

Treatment:

Device: Akreos® MI60 intraocular lens