Cataract SenileNCT07092020
Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)
A study testing EDF and Monofocal IOL in people with Cataract Senile, run by Carl Zeiss Meditec AG at 14 sites in 4 countries.
Trial summary
Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Senile
- What is being tested?
- EDF and Monofocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 1 Oct 2025to 27 Jul 2026
- 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
- Patients of any gender, aged 18 years or older
- Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement
- Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
- Calculated lens power within the available range
- Clear intraocular media other than cataract
- Patient is willing and capable of providing informed consent
- Patient is willing and capable of complying with visits and procedures as defined by this protocol
Who cannot join
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- Endothelial cell count of less than 2000/mm2
- Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia
- Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.)
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- Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
- Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study
- Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk
- Clinically significant gonioscopic abnormalities
- Amblyopia, strabismus, single eye status
- Rubella, congenital, traumatic or complicated cataracts
- History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
- Microphthalmos or macrophthalmos
- Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)
- Pseudoexfoliation
- Keratoconus or irregular astigmatism
- Inability to measure keratometry or biometry (including but not limited to cataract density, etc.)
- Pathologic miosis
- Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes
- Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
- Patients whose freedom is impaired by administrative or legal order
- Concurrent participation in another clinical investigation in the last 30 days.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Spain5 sites
Oftalvist
Alicante
Hospital Universitario Ramón y Cajal
Madrid
OMIQ Hospital Universitari
Sant Cugat del Vallès
University Hopital Complex of Santiago de Compostela
Santiago de Compostela
Oftalvist
Valencia
Bulgaria3 sites
Eye Hospital Zora
Sofia
Specialized Ophthalmological Hospital for Active Treatment
Sofia
Medical Center "Vereya"
Stara Zagora
Czechia3 sites
Nemocnice Havlíčkův
Havlíčkův Brod
OFTEX ocni
Pardubice
Oční Centrum
Prague
Romania3 sites
Oculus Eye Clinic
Bucharest
Ofta Total Clinic
Sibiu
Medoptic Clinic
Suceava
About this study
Official title: A Prospective, Randomized, Controlled, Observer-masked, Multi-center Clinical Trial to Demonstrate the Safety and Effectiveness of the Extended Depth of Focus AT LARA 829MP Posterior Chamber Intraocular Lens for Correction of Aphakia
Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)
Read the detailed description
Extended depth of Focus intraocular lens versus a monofocal intraocular lens
- Conditions
- Cataract Senile
- Being tested
- EDF, Monofocal IOL
- Keywords
- IOL, Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDFDevice
Extended depth of focus
Monofocal IOLDevice
Monofocal
| Study group | Role | What they receive |
|---|---|---|
| Extended depth of focus (EDF) | Experimental | Extended depth of focus Receives: Device: EDF |
| Monofocal | Active comparator | Monofocal Receives: Device: Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Measured: 6 Months
Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m
Measured: 6 Months
Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus)
Measured: 6 Months
Mean monocular negative defocus range at the 0.20 logMAR compared to control
Measured: 6 Months
Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better
Measured: 6 Months
Secondary outcomes (1)
Patient Reported Outcome (PRO)
Proportion of subjects who respond "I didn't wear glasses or contact lenses at all in the last 7 days" to question "How often did you wear glasses or contact lenses to see in the last 7 days?" from Patient Reported Outcome (PRO) survey
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Oct 2025
- Primary completion27 Jul 2026
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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, Investigator
- Enrolment
- 220 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
- NCT07092020
- Sponsor's protocol ID
- AT LARA 829MP BER-401-24
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Observer-masked, Multi-center Clinical Trial to Demonstrate the Safety and Effectiveness of the Extended Depth of Focus AT LARA 829MP Posterior Chamber Intraocular Lens for Correction of Aphakia
- ClinicalTrials.gov ID
- NCT07092020
- Acronym / sponsor ID
- AT LARA 829MP BER-401-24
- Conditions
- Cataract Senile
- Keywords
- IOL, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 27 Jul 2026 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 29 Jul 2025 (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.
Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)
Detailed description
Extended depth of Focus intraocular lens versus a monofocal intraocular lens
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended depth of focus (EDF) | Experimental | Device: EDFExtended depth of focus |
| Monofocal | Active comparator | Device: Monofocal IOLMonofocal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of any gender, aged 18 years or older
- Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement
- Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
- Calculated lens power within the available range
- Clear intraocular media other than cataract
Key exclusion criteria (23 listed)
- Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
- Endothelial cell count of less than 2000/mm2
- Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
- Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study
- Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia
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 |
|---|---|---|
| EDFExtended depth of focus | Device | Extended depth of focus (EDF) |
| Monofocal IOLMonofocal | Device | Monofocal |
Primary outcome
Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm
Time frame: 6 Months
Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m
Time frame: 6 Months
Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus)
Time frame: 6 Months
Mean monocular negative defocus range at the 0.20 logMAR compared to control
Time frame: 6 Months
Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better
Time frame: 6 Months
1 secondary outcome
Patient Reported Outcome (PRO)
Time frame: 6 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 17 Aug 2026.
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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.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDF and Monofocal IOL in people with Cataract Senile, run by Carl Zeiss Meditec AG at 14 sites in 4 countries.
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 23 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Bulgaria, Czechia, Romania. 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?
Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm (time frame: 6 Months). The study lists 5 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 17 Aug 2026.