Cataract
Conditions
Keywords
Compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs 6 months post cataract surgery.
Brief summary
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR intraocular lenses (IOLs) 6 months post cataract surgery.
Interventions
Sponsors
Innovative Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or greater * Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes * Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation * Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40 * Naturally dilated pupil size (in dim light) \> 3.5 mm (with no dilation medications) for both eyes * Preoperative corneal astigmatism of 1.0 D or less * Clear intraocular media other than cataract * Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
Exclusion criteria
* Use of systemic or ocular medications that may affect vision * Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) * Subjects with diabetes mellitus * Uncontrolled systemic or ocular disease * History of ocular trauma or prior ocular surgery * Amblyopia or strabismus * Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) * Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse * Subjects who may be expected to require retinal laser treatment or other surgical intervention * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions) * Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses * Requiring an intraocular lens \<15.0 or \>26.0 diopters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refraction | 1 year |
| Distance Visual Acuities | 1 year |
Countries
United States
Outcome results
None listed