Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)

Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)

To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.

The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.

Inclusion Criteria:

• Visual potential of 20/30 or better in each study eye
• Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
• Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
• Preoperative corneal astigmatism of 1.0 D or less

Exclusion Criteria:

• Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)

• Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)

• Uncontrolled systemic or ocular disease

• History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention

• Presence of ocular pathology other than cataract such as:

  • Amblyopia or strabismus
  • Corneal abnormalities
  • Pupil abnormalities
  • Capsule or zonule abnormalities
  • Intraocular inflammation
  • Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)

• Requiring an intraocular lens outside the study diopter range

• Contact lens usage prior to study procedure (time interval dependent upon contact lens type)