CataractVENUStoricNCT03839420
To Compare Early Rotation of Two Extended Depth of Focus Intraocular Lenses
A study testing CZM IOL and Competitor IOL in people with Cataract, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- CZM IOL and Competitor IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jul 2019to 17 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
- Patients of any gender, aged 18 or older
- Assured follow-up examinations
- Healthy eyes with clinically significant age related cataract requiring surgical treatment
- Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
- Uni- and/or bilaterally regular corneal astigmatism ≥ 1.0 D and ≤ 3.0 D (confirmed by topography measurement)
- 8. Cataract density compatible with biometry measurement
Who cannot join
- Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- Current participation in another drug or device investigation that affects patients vision
- Ocular disorders, other than cataract, that could potentially cause future acuity loss
- Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.)
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- Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
- Any condition in the study eye that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, Floppy iris syndrome etc.)
- History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis
- Pseudoexfoliation syndrome (according to investigator decision)
- Pathologic miosis or Pharmacotherapy with miotic agent
- Irregular astigmatism / Keratoconus
- Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment.
- All kind of infections (acute ocular disease, external / internal infection, systemic infection)
- Traumatic cataract
- Monophthalmic patient
- Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus
- Patient expected to require retinal laser treatment before the end of the last follow-up examination
- Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination
- Previous intraocular and corneal / refractive surgery
- Current Systemic or ocular pharmacotherapy that effects patients vision (according to investigator decision)
- Dementia
- Previous use of cytotoxic drugs or total body irradiation within last 2 years
- Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- Pregnancy and / or lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.
- Conditions
- Cataract
- Being tested
- CZM IOL, Competitor IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CZM IOLDevice
implantation of CZM IOL
Competitor IOLDevice
implantation of Competitor IOL
| Study group | Role | What they receive |
|---|---|---|
| CZM IOL | Experimental | Not described Receives: Device: CZM IOL |
| Competitor IOL | Active comparator | Not described Receives: Device: Competitor IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL axis
IOL axis will be analyzed based on images.
Measured: Immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start8 Jul 2019
- Primary completion4 Oct 2020
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative randomized trial
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839420
- Sponsor's protocol ID
- 929MP BER-401-18
- Acronym
- VENUStoric
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Early Rotation of Two Extended Depth of Focus Intraocular Lenses
- ClinicalTrials.gov ID
- NCT03839420
- Acronym / sponsor ID
- VENUStoric / 929MP BER-401-18
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 4 Oct 2020 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that the Carl Zeiss Meditec (CZM) Extended depth of focus (EDOF) Intraocular lens (IOL) is superior to the competitor EDOF IOL with respect to Rotational Stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparative randomized trial
| Arm | Type | Receives |
|---|---|---|
| CZM IOL | Experimental | Device: CZM IOL |
| Competitor IOL | Active comparator | Device: Competitor IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent
- Patients of any gender, aged 18 or older
- Assured follow-up examinations
- Healthy eyes with clinically significant age related cataract requiring surgical treatment
- Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment
Key exclusion criteria (25 listed)
- Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- Current participation in another drug or device investigation that affects patients vision
- Ocular disorders, other than cataract, that could potentially cause future acuity loss
- Have atonic pupil or physiologically small pupil (unable to dilate to at least 5 mm)
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 |
|---|---|---|
| CZM IOLimplantation of CZM IOL | Device | CZM IOL |
| Competitor IOLimplantation of Competitor IOL | Device | Competitor IOL |
Primary outcome
IOL axis
Time frame: Immediately after the surgery
IOL axis will be analyzed based on images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CZM IOL and Competitor IOL in people with Cataract, run by Carl Zeiss Meditec AG at 1 site in Germany.
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 7 inclusion and 25 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IOL axis (time frame: Immediately after the surgery). 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 8 Feb 2023.