Phase 4
Completed N=70
Clinical Evaluation of the One-Piece Tecnis Multifocal Intraocular Lens (IOL)
Source: ClinicalTrials.gov NCT01210807 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm — 0.07; 0.61 logMAR visual acuity
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm |
0.07; 0.61 | — |
| SECONDARY Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity |
32; 31 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01210807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.