CataractPhase 4NCT01210807

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

A Phase 4 study testing One-Piece Tecnis Multifocal IOL and One-Piece Tecnis monofocal IOL, Model ZCB00 in people with Cataract, run by Abbott Medical Optics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cataract
What is being tested?: One-Piece Tecnis Multifocal IOL and One-Piece Tecnis monofocal IOL, Model ZCB00
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: No sites listed yet
Study dates: Nov 2009to Aug 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

bilateral cataracts and otherwise healthy eyes
visual potential of Decimal 0.8 in each eye

Who cannot join

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

About this study

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

Conditions: Cataract
Being tested: One-Piece Tecnis Multifocal IOL, One-Piece Tecnis monofocal IOL, Model ZCB00
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

One-Piece Tecnis Multifocal IOLDevice
Also called Model ZMB00
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
One-Piece Tecnis monofocal IOL, Model ZCB00Device
Also called ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.

Study groups in NCT01210807
Study group	Role	What they receive
Multifocal Intraocular Lens	Experimental	ZMB00 multifocal intraocular lens Receives: Device: One-Piece Tecnis Multifocal IOL
Monofocal Intraocular Lens	Active comparator	ZCB00 monofocal intraocular lens Receives: Device: One-Piece Tecnis monofocal IOL, Model ZCB00

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
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.
Measured: 4-6 Months

Secondary outcomes (1)

Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
Measured: 4-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Aug 2011

First posted29 Sep 2010 (estimated)
Study startNov 2009
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01210807
Sponsor's protocol ID: DIOL-105-TMF1
Status last verified: Jan 2025
First submitted: 17 Jun 2010
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the One-Piece Tecnis Multifocal IOL, Model ZMB00
ClinicalTrials.gov ID: NCT01210807
Acronym / sponsor ID: DIOL-105-TMF1
Conditions: Cataract
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 29 Sep 2010 (estimated)
Results: Posted 13 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Multifocal Intraocular Lens	Experimental	Device: One-Piece Tecnis Multifocal IOLZMB00 multifocal intraocular lens
Monofocal Intraocular Lens	Active comparator	Device: One-Piece Tecnis monofocal IOL, Model ZCB00ZCB00 monofocal intraocular lens

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

bilateral cataracts and otherwise healthy eyes
visual potential of Decimal 0.8 in each eye

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
One-Piece Tecnis Multifocal IOLAlso: Model ZMB00One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.	Device	Multifocal Intraocular Lens
One-Piece Tecnis monofocal IOL, Model ZCB00Also: ZCB00Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.	Device	Monofocal Intraocular Lens

Primary outcome

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.

1 secondary outcome

Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
Time frame: 4-6 months

Results and safety

Results posted to the registry on 13 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ZMB00 Multifocal Intraocular Lens	36	33
ZCB00 Monofocal Intraocular Lens	34	31

Primary outcome: Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm

Time frame: 4-6 Months. Mean (Standard Deviation). Unit: logMAR visual acuity

Measure	ZMB00 Multifocal Intraocular Lens n = 33	ZCB00 Monofocal Intraocular Lens n = 31
Value	0.07 (0.12)	0.61 (0.15)

Population analysed: Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZMB00 Multifocal Intraocular Lens	0 of 36 (0%)	3 of 36 (8.3%)	Not reported
ZCB00 Monofocal Intraocular Lens	0 of 34 (0%)	4 of 34 (11.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
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Active, not recruitingObservational study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Szurman, PD Dr. med. principal investigator

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing One-Piece Tecnis Multifocal IOL and One-Piece Tecnis monofocal IOL, Model ZCB00 in people with Cataract, run by Abbott Medical Optics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm (time frame: 4-6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01210807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.