CataractNCT00747565
Safety and Effectiveness of a Multifocal Intraocular Lens (IOL)
A study testing Tecnis ZM900 Multifocal Intraocular Lens and CeeOn 911A monofocal IOL in people with Cataract, run by Abbott Medical Optics.
Trial summary
To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900… 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?
- Tecnis ZM900 Multifocal Intraocular Lens and CeeOn 911A monofocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Nov 2008
- Phase
- Interventional
- 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
- Visual potential of 20/30 or better in each study eye
- Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
- Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
- Preoperative corneal astigmatism of 1.0 D or less
Who cannot join
- Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
- Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
- Presence of ocular pathology other than cataract such as:
- Amblyopia or strabismus
Show all 13Show fewer
- Corneal abnormalities
- Pupil abnormalities
- Capsule or zonule abnormalities
- Intraocular inflammation
- Known pathology that may affect visual acuity and/or are predicted to cause future acuity losses to a level of 20/30 or worse (e.g. macular degeneration)
- Requiring an intraocular lens outside the study diopter range
- Contact lens usage prior to study procedure (time interval dependent upon contact lens type)
About this study
Official title: Clinical Evaluation of the Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)
To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.
Read the detailed description
The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.
- Conditions
- Cataract
- Being tested
- Tecnis ZM900 Multifocal Intraocular Lens, CeeOn 911A monofocal IOL
- Keywords
- cataract, tecnis, multifocal, intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecnis ZM900 Multifocal Intraocular LensDevice
Investigational intraocular lens
CeeOn 911A monofocal IOLDevice
Monofocal Control IOL
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Multifocal IOL group | Experimental | Subjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints. Receives: Device: Tecnis ZM900 Multifocal Intraocular Lens |
| CeeOn 911A monofocal control IOL group | Active comparator | Subjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints. Receives: Device: CeeOn 911A monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
Measured: One year
Mean Binocular Distance Corrected Near Visual Acuity in Snellen
Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startNov 2004
- Primary completionJan 2008
- Study completionNov 2008
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Packer, M.D., Principal investigator, Drs. Fine, Hoffman and Packer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747565
- Sponsor's protocol ID
- DIOL-104-TCNS & DIOL-101-TCNS
- Status last verified
- Jan 2025
- First submitted
- 3 Sep 2008
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Tecnis Multifocal Intraocular Lens (IOL), Model ZM900, Original Study (DIOL-101-TCNS); Clinical Evaluation of the Tecnis Multifocal Intraocular Lens, Model ZM900, Expansion Study (DIOL-104-TCNS)
- ClinicalTrials.gov ID
- NCT00747565
- Acronym / sponsor ID
- DIOL-104-TCNS & DIOL-101-TCNS
- Conditions
- Cataract
- Keywords
- cataract, tecnis, multifocal, intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 2 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the ZM900 Tecnis Multifocal lens. Results from two studies (an original study with 125 multifocal and 123 monofocal subjects, protocol DIOL-101-TCNS, and an expansion study with 222 additional multifocal subjects, protocol DIOL-104-TCNS) are combined to evaluate the ZM900 Tecnis Multifocal lens vs. a monofocal control. The original study was conducted in 2004-2006; the expansion study was conducted in 2007-2008. Results from both studies were analyzed together for FDA approval.
Detailed description
The original study was protocol DIOL-101-TCNS; the expansion study was protocol DIOL-104-TCNS. The study protocols were almost identical with the exception that no control subjects were enrolled in the expansion study; only additional multifocal subjects. All eligibility criteria and testing conducted in the expansion study was the same as that in the original study. The hypotheses were that best corrected distance visual acuity of the ZM900 lens would meet or exceed the FDA grid values, complication and adverse event rates of the ZM900 would be similar to the FDA grid rates for posterior chamber IOLs, and near visual acuity of the ZM900 lens would be improved compared to that of the monofocal control lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis Multifocal IOL group | Experimental | Device: Tecnis ZM900 Multifocal Intraocular LensSubjects implanted bilaterally with the Tecnis Multifocal IOL. Participants were enrolled in this arm in the original study and also in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints. |
| CeeOn 911A monofocal control IOL group | Active comparator | Device: CeeOn 911A monofocal IOLSubjects implanted bilaterally with the CeeOn 911A monofocal IOL. Participants enrolled in this arm only in the original study; no control subjects were enrolled in the expansion study. Outcomes of the first eye of each subject were analyzed for the primary study endpoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Visual potential of 20/30 or better in each study eye
- Preoperative BCDVA worse than Snellen 20/40 or worse than 20/30 in the presence of glare (as measured using a Snellen chart with BAT at medium)
- Naturally dilated pupil size (in dim light) > 4.0 mm (with no dilation medications) for each study eye
- Preoperative corneal astigmatism of 1.0 D or less
Key exclusion criteria (13 listed)
- Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
- Acute or chronic disease or illness that would increase the operative risk or confound the study outcome(s),(e.g., diabetes mellitus, immunocompromised, connective tissue disease, etc.)
- Uncontrolled systemic or ocular disease
- History of ocular trauma or prior ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention
- Presence of ocular pathology other than cataract such as:
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 |
|---|---|---|
| Tecnis ZM900 Multifocal Intraocular LensInvestigational intraocular lens | Device | Tecnis Multifocal IOL group |
| CeeOn 911A monofocal IOLMonofocal Control IOL | Device | CeeOn 911A monofocal control IOL group |
Primary outcome
Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye.
Time frame: One year
Number of participants that achieved a best corrected distance visual acuity of 20/40 or better in the first eye. As most subjects were implanted bilaterally,"first eye" refers to the first implanted eye of each subject.
Mean Binocular Distance Corrected Near Visual Acuity in Snellen
Time frame: One year
Mean binocular near visual acuity with distance correction in place measured at 33 cm; Mean is reported in Snellen (e.g. 20/20, 20/40, etc.), standard deviation reported in ETDRS (Early treatment diabetic retinopathy study)eye chart log units.
Results and safety
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.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
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
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Mark Packer, M.D. principal investigator
Drs. Fine, Hoffman and Packer
Questions about this trial
What is this clinical trial studying?
A study testing Tecnis ZM900 Multifocal Intraocular Lens and CeeOn 911A monofocal IOL 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 4 inclusion and 13 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2010). 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?
Number of Participants That Achieved Best Corrected Distance Visual Acuity of 20/40 or Better in the First Eye. (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.