CataractNCT03172351
EDoF IOLs vs Monofocal IOL
A study testing EDoF1, Monofocal and EDoF2 in people with Cataract, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
prospective, comparative (3 arms), randomized, multicentric clinical trial Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- EDoF1, Monofocal and EDoF2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteGermany
- Study dates
- 24 May 2017to 1 Apr 2019
- 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
- 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 50 to 80 years;
- Assured follow-up examinations;
- clinically significant bilateral cataract;
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;
- Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
- Pseudoexfoliations syndrome
Show all 27Show fewer
- Pathologic miosis or Pharmacotherapy with miotic agent
- Keratoconus
- Chronic or recurrent uveitis
- Diabetic retinopathy
- Uncontrolled glaucoma and or IOP>24mmHg
- Choroidal hemorrhage,
- All kind of infections (acute ocular disease, external/internal infection, systemic infection)
- Traumatic cataract
- Aniridia
- Microphthalmia
- Amblyopia
- Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
- Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up
- Previous intraocular and corneal surgery
- Expected postop. astigmatism greater than 1 D
- Any type of corneal disorder
- Systemic or ocular pharmacotherapy, which can impact the visual acuity,
- Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion
- Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)
- Dementia
- pregnancy or lactation period for female patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
prospective, comparative (3 arms), randomized, multicentric clinical trial
- Conditions
- Cataract
- Being tested
- EDoF1, Monofocal, EDoF2
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDoF1Device
extended depth of focus IOL - EDoF1
MonofocalDevice
Monofocal IOL
EDoF2Device
Comparison EDoF2 IOL
| Study group | Role | What they receive |
|---|---|---|
| EDoF1 | Experimental | Not described Receives: Device: Monofocal; Device: EDoF2 |
| Monofocal | Active comparator | Not described Receives: Device: EDoF1; Device: EDoF2 |
| EDoF2 | Active comparator | Not described Receives: Device: EDoF1; Device: Monofocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defocus curve measurement
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start24 May 2017
- Primary completion1 Jan 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 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
- NCT03172351
- Sponsor's protocol ID
- AT LARA 829MP BER-401-16
- Status last verified
- Jul 2020
- First submitted
- 24 May 2017
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reinhard T, Maier P, Bohringer D, Bertelmann E, Brockmann T, Kiraly L, Salom D, Piovella M, Colonval S, Mendicute J. Comparison of two extended depth of focus intraocular lenses with a monofocal lens: a multi-centre randomised trial. Graefes Arch Clin Exp Ophthalmol. 2021 Feb;259(2):431-442. doi: 10.1007/s00417-020-04868-5. Epub 2020 Sep 11.
PubMed 32915276
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT03172351
- Acronym / sponsor ID
- AT LARA 829MP BER-401-16
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 1 Jun 2017 (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.
prospective, comparative (3 arms), randomized, multicentric clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDoF1 | Experimental | Device: Monofocal, Device: EDoF2 |
| Monofocal | Active comparator | Device: EDoF1, Device: EDoF2 |
| EDoF2 | Active comparator | Device: EDoF1, Device: Monofocal |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 50 to 80 years;
- Assured follow-up examinations;
- clinically significant bilateral cataract;
Key exclusion criteria (27 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;
- Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye
- Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)
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 |
|---|---|---|
| EDoF1extended depth of focus IOL - EDoF1 | Device | EDoF2, Monofocal |
| MonofocalMonofocal IOL | Device | EDoF1, EDoF2 |
| EDoF2Comparison EDoF2 IOL | Device | EDoF1, Monofocal |
Primary outcome
Defocus curve measurement
Time frame: 1 month
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 16 Jul 2020.
- Derived from this study: PubMed 32915276Reinhard T, Maier P, Bohringer D, Bertelmann E, Brockmann T, Kiraly L, Salom D, Piovella M, Colonval S, Mendicute J. Comparison of two extended depth of focus intraocular lenses with a monofocal lens: a multi-centre randomised trial. Graefes Arch Clin Exp Ophthalmol. 2021 Feb;259(2):431-442. doi: 10.1007/s00417-020-04868-5. Epub 2020 Sep 11.
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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 EDoF1, Monofocal and EDoF2 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 4 inclusion and 27 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 16 Jul 2020. 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?
Defocus curve measurement (time frame: 1 month). 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 NCT03172351, which also lists 1 linked publication.
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 16 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.