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

Abbott

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: One-Piece Tecnis monofocal IOL, Model ZCB00; Device: One-Piece Tecnis Multifocal IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210807

DIOL-105-TMF1

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Multifocal Intraocular Lens

Experimental group

Description:

ZMB00 multifocal intraocular lens

Treatment:

Device: One-Piece Tecnis Multifocal IOL

Monofocal Intraocular Lens

Active Comparator group

Description:

ZCB00 monofocal intraocular lens

Treatment:

Device: One-Piece Tecnis monofocal IOL, Model ZCB00