Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Abbott Medical Optics
- Enrollment
- 70
- Primary Endpoint
- Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Monofocal Intraocular Lens
ZCB00 monofocal intraocular lens
Intervention: One-Piece Tecnis monofocal IOL, Model ZCB00 (Device)
Multifocal Intraocular Lens
ZMB00 multifocal intraocular lens
Intervention: One-Piece Tecnis Multifocal IOL (Device)
Outcomes
Primary Outcomes
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
Time Frame: 4-6 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 Outcomes
- Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity(4-6 months)