Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens Aspheric Optic (AO)

Prospective Evaluation of Visual Outcomes With Tecnis One-Piece Multifocal Intraocular Lenses Compared With Patients Previously Implanted With Crystalens AO

The study is being conducted to collect information about visual outcomes and participant satisfaction with the Tecnis One-Piece Multifocal (MF) Intraocular Lenses (IOLs) compared with participants previously implanted with Crystalens Aspheric Optic (AO) IOLs. The U.S. Food and Drug Administration (FDA) has cleared the Tecnis One-Piece MF IOL for visual correction of aphakia (replacing a removed lens in the eye) in adults.

Inclusion Criteria:

• Key Inclusion Criteria for Part 1:

  • 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 (BCDVA) worse than 20/40 Snellen
  • Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
  • Preoperative corneal astigmatism of 1.5 D or less
  • Clear intraocular media other than cataract
  • Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Inclusion Criteria for Part 2

• At least 18 years of age
• Underwent bilateral implantation with Crystalens AO at least 6 months previously
• Visual potential of 20/30 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) > 3.5 mm (with no dilation medications) for both eyes
• Preoperative corneal astigmatism of 1.5 D or less
• Clear intraocular media other than cataract
• Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

• Key Exclusion Criteria for Part 1:

  • 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
  • Patients with forme fruste keratoconus or keratoconus
  • 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

Exclusion Criteria for Part 2

• 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
• Patients with forme fruste keratoconus or keratoconus
• 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)
• Requiring an intraocular lens <15.0 or >26.0 diopters Exclusion Criteria for Part 2
• 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
• Patients with forme fruste keratoconus or keratoconus
• 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)
• Requiring an intraocular lens <15.0 or >26.0 diopters