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

Completed · Phase 4

Conditions studied: Cataract

In brief

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

Key facts

Study ID

NCT01275118

Run by

Mark Packer, MD, FACS

People needed

26

Starts

2010-12-01

Expected to finish

2011-09-01

Last updated by the study team

2014-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Drs. Fine, Hoffman and Packer, LLC — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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