Comparison of Postoperative Visual Acuity and Spectacle Independence Between the Tecnis Multifocal Intraoculer Lens (IOL) and the Crystalens Accommodating IOL

Mark Packer, MD, FACS

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: Tecnis Multifocal IOL

Device: crystalens Accommodating IOL

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01275118

TMF-09-002 Rev.5

Details and patient eligibility

About

Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older
Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion criteria

Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
Use of systemic or ocular medications that may affect visual outcomes
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
Uncontrolled systemic or ocular disease
History of ocular trauma
History of ocular surgery other than that required for inclusion in this study
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 worse than 20/30
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 or abnormally shaped pupils)