Visual AcuityNCT02990689
Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
A study testing Trifocal Intraocular Lens, Bifocal Intraocular Lens and Low Addition Bifocal Intraocular Lens in people with Visual Acuity, run by Carl Zeiss Meditec AG.
Trial summary
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Trifocal Intraocular Lens, Bifocal Intraocular Lens and Low Addition Bifocal Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Oct 2015
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of any gender, aged 50 to 80 years
- Signed informed consent form
- Healthy eyes besides cataract
- Assured follow-up examinations
- Stable corneal conditions within the last 12 months
- Corneal astigmatism less than 1D
- Implantation into the capsular bag by injector
Who cannot join
- Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- Pseudophakia
- Cornea guttata; keratoplasty
- Irregular astigmatism (e.g. Keratoconus)
- Corneal scarring
- Diabetic retinopathy
Show all 19Show fewer
- Aniridia
- Amblyopia
- Amotio operation; anamnesis with vitreous surgery
- Pseudoexfoliation Syndrome; Uveitis
- Previous intraocular and corneal surgery
- Intraocular tumours; endotamponade
- Glaucoma or IOP higher than 24mmHg
- Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
- Need for a dioptre out of the range of +16.0D to +26.0D
- Inability to achieve secure lens placement in the capsular bag
- Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
- Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
- Pregnancy or lactation period for female patients
About this study
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.
- Conditions
- Visual Acuity
- Being tested
- Trifocal Intraocular Lens, Bifocal Intraocular Lens, Low Addition Bifocal Intraocular Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifocal Intraocular LensDevice
bifocal intraocular lens (IOL)
Bifocal Intraocular LensDevice
trifocal intraocular lens (IOL)
Low Addition Bifocal Intraocular LensDevice
low near addition intraocular lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| 809M | Active comparator | bifocal intraocular lens (IOL) Receives: Device: Bifocal Intraocular Lens |
| 839MP | Active comparator | trifocal intraocular lens (IOL) Receives: Device: Trifocal Intraocular Lens |
| SN6AD1 | Active comparator | bifocal intraocular lens (IOL) Receives: Device: Low Addition Bifocal Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermediate visual acuity
Measured: 12 months
Secondary outcomes (2)
Distance visual acuity
Measured: 12 months
Near visual acuity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 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
- NCT02990689
- Sponsor's protocol ID
- LISA tri 839MP HEN 301-11
- Status last verified
- Sep 2018
- First submitted
- 6 Dec 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs
- ClinicalTrials.gov ID
- NCT02990689
- Acronym / sponsor ID
- LISA tri 839MP HEN 301-11
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 809M | Active comparator | Device: Bifocal Intraocular Lensbifocal intraocular lens (IOL) |
| 839MP | Active comparator | Device: Trifocal Intraocular Lenstrifocal intraocular lens (IOL) |
| SN6AD1 | Active comparator | Device: Low Addition Bifocal Intraocular Lensbifocal intraocular lens (IOL) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of any gender, aged 50 to 80 years
- Signed informed consent form
- Healthy eyes besides cataract
- Assured follow-up examinations
- Stable corneal conditions within the last 12 months
Key exclusion criteria (19 listed)
- Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- Pseudophakia
- Cornea guttata; keratoplasty
- Irregular astigmatism (e.g. Keratoconus)
- Corneal scarring
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 |
|---|---|---|
| Trifocal Intraocular Lensbifocal intraocular lens (IOL) | Device | 839MP |
| Bifocal Intraocular Lenstrifocal intraocular lens (IOL) | Device | 809M |
| Low Addition Bifocal Intraocular Lenslow near addition intraocular lens (IOL) | Device | SN6AD1 |
Primary outcome
Intermediate visual acuity
Time frame: 12 months
2 secondary outcomes
Distance visual acuity
Time frame: 12 months
Near visual acuity
Time frame: 12 months
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 6 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Trifocal Intraocular Lens, Bifocal Intraocular Lens and Low Addition Bifocal Intraocular Lens in people with Visual Acuity, run by Carl Zeiss Meditec AG.
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 19 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 6 Sep 2018. 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?
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?
Intermediate visual acuity (time frame: 12 months). 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 6 Sep 2018.