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Clinical Trials/NCT00760058
NCT00760058
Withdrawn
Phase 4

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

Alcon Research1 site in 1 countryJune 2008
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Withdrawn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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
December 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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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