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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-Piece Tecnis Multifocal IOL

Device

One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.

Other names: Model ZMB00

One-Piece Tecnis monofocal IOL, Model ZCB00

Device

Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.

Other names: ZCB00

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

Time frame: 4-6 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Sep 29, 2010
Registry last updated: Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed