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

NCT ID: NCT01210807

Last Updated: 2025-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multifocal Intraocular Lens

ZMB00 multifocal intraocular lens

Group Type EXPERIMENTAL

One-Piece Tecnis Multifocal IOL

Intervention Type DEVICE

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

Monofocal Intraocular Lens

ZCB00 monofocal intraocular lens

Group Type ACTIVE_COMPARATOR

One-Piece Tecnis monofocal IOL, Model ZCB00

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

One-Piece Tecnis Multifocal IOL

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

Intervention Type DEVICE

One-Piece Tecnis monofocal IOL, Model ZCB00

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Model ZMB00 ZCB00

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Optics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Szurman, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DIOL-105-TMF1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.