NCT00760058
Withdrawn
Phase 4
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
ConditionsCataract
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Alcon Research
- Locations
- 1
- Primary Endpoint
- Contrast sensitivity
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Contrast sensitivity
Time Frame: 3 months
Secondary Outcomes
- Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.(3 months)
Study Sites (1)
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