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Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)

Phase 4
Completed
Conditions
Cataract
Registration Number
NCT01210807
Lead Sponsor
Abbott Medical Optics
Brief Summary

The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
Inclusion Criteria
  • bilateral cataracts and otherwise healthy eyes
  • visual potential of Decimal 0.8 in each eye
Exclusion Criteria
  • any medications affecting vision
  • any chronic disease/illness that would affect risk to subject or outcomes of the study
  • any ocular pathology/abnormalities that may affect visual outcomes or confound study results
  • desire for monovision

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm4-6 Months

Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.

Secondary Outcome Measures
NameTimeMethod
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity4-6 months

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