Cataract
Conditions
Keywords
cataract, intraocular lens
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.
Interventions
DEVICEAcrySof® IQ IOL
Replacement of natural crystalline lens in cataract surgery
DEVICETecnis® Aspheric intraocular lens
Replacement of natural crystalline lens in cataract surgery
DEVICEAkreos® MI60 intraocular lens
Replacement of natural crystalline lens in cataract surgery
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contrast sensitivity | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction. | 3 months |
Countries
United States
Outcome results
None listed