Evaluation of the Tecnis™ Multifocal and Crystalens™ Accommodating Intraocular Lenses

Innovative Medical

Status and phase

Completed

Phase 4

Conditions

Aphakia

Treatments

Device: Tecnis MF IOL

Device: Crystalens AO IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT01061281

Tecnis MF/Crystalens

Details and patient eligibility

About

The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and Crystalens™ AO Aberration-free Accommodating intraocular lens (IOLs) 6 months after post cataract surgery.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 20/25 or better in each eye after cataract removal and IOL implantation
Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/40 Snellen
Naturally dilated pupil size (in dim light) > 4.0 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 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