CataractVISUALNCT06111222
Visual Performance of Patients Implanted With a Multifocal IOL
A study testing AT ELANA in people with Cataract and Refractive Lens Exchange, run by Carl Zeiss Meditec AG at 3 sites in 2 countries.
Trial summary
The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Refractive Lens Exchange
- What is being tested?
- AT ELANA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 31 Oct 2023to 13 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D
- No visual acuity limiting pathologies other than cataract;
- Corneal Astigmatism of <1.0 D;
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;
- Written informed consent for participation in the study and data protection.
Who cannot join
- Corneal Astigmatism of ≥1.0 D;
- Difficulty for cooperation (distance from their home, general health conditions);
- History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);
- Visual field loss which has an impact on visual acuity;
- Use of systemic or ocular medication that might affect vision;
- Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
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- Pupil abnormalities (non-reactive, tonic pupils, abnormal myosis or mydriasis, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions);
- Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g., pseudoexfoliation syndrome);
- Cataract grades of 4, 5 or 6 on the LOCSIII scale ;
- Surgeries with incision size of ≥2.75mm ;
- Immediate Sequential Bilateral Cataract Surgery ;
- Concurrent participation in another device investigation;
- Usage of contact lenses during participation.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Universitätsklinikum Heidelberg
Heidelberg, 69120
PVK Precise Vision GmbH
Rheine, 48429
About this study
Official title: Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens
The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.
- Conditions
- Cataract, Refractive Lens Exchange
- Being tested
- AT ELANA
- Keywords
- cataract, multifocal IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT ELANADevice
The device is CE-approved. The device is a posterior chamber multifocal intraocular lens (IOL) indicated for aphakia after surgical extraction of the cataractous natural lens. The device is also indicated for non-cataractous, presbyopic patients (PRELEX) who seek greater independence from glasses for intermediate and/or near distances. It is an aspheric (aberration-neutral) IOL made of hydrophobic acrylic material, coated with heparin with modified C-loop haptics.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral implantation of investigational device | Other | Bilateral implantation of investigational device Receives: Device: AT ELANA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean monocular best-corrected distance visual acuity (CDVA)
The objective is to evaluate Corrected Distance Visual Acuity (CDVA)
Measured: Three (3) Months
Secondary outcomes (1)
Refractive Predictability / Manifest Refraction and Prediction Error
Descriptive analysis of the manifest refraction parameters sphere, cylinder, and spherical equivalent (MRSE) will be reported to determine refractive predictability
Measured: Twelve (12) Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start31 Oct 2023
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT06111222
- Sponsor's protocol ID
- GPAS-SUR-021-01
- Acronym
- VISUAL
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Study on the Visual Performance of Patients Implanted With a Multifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT06111222
- Acronym / sponsor ID
- VISUAL / GPAS-SUR-021-01
- Conditions
- Cataract, Refractive Lens Exchange
- Keywords
- cataract, multifocal IOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 1 Nov 2023 (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.
The goal of this clinical trial is to learn about the visual performance of a new multifocal intra-ocular lens in patients presenting for cataract or refractive lens exchange surgery. The main question it aims to answer is: What is the visual performance and patient satisfaction twelve months post-operatively? Participants will receive bilateral implantation of the investigational device, undergo post-operative assessments, and provide feedback on their overall visual satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients scheduled for cataract or refractive lens exchange surgery requiring bilateral implantation of multifocal IOL
| Arm | Type | Receives |
|---|---|---|
| Bilateral implantation of investigational device | Other | Device: AT ELANABilateral implantation of investigational device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older;
- Patients scheduled for bilateral AT ELANA 841P phacoemulsification cataract extraction or Femtosecond-Laser-Assisted-Cataract-Surgery (cataract grades of 1, 2, 3 on the LOCSIII scale) and IOL implantation (Cataract or PRELEX) with a maximum of 28 days between both implantations; Calculated IOL power within the limited IOL Diopter range of +15.0D to +27.0D
- No visual acuity limiting pathologies other than cataract;
- Corneal Astigmatism of <1.0 D;
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures;
Key exclusion criteria (13 listed)
- Corneal Astigmatism of ≥1.0 D;
- Difficulty for cooperation (distance from their home, general health conditions);
- History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, OHT, glaucoma suspect, glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc.);
- Visual field loss which has an impact on visual acuity;
- Use of systemic or ocular medication that might affect vision;
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 |
|---|---|---|
| AT ELANAThe device is CE-approved. The device is a posterior chamber multifocal intraocular lens (IOL) indicated for aphakia after surgical extraction of the cataractous natural lens. The device is also indicated for non-cataractous, presbyopic patients (PRELEX) who seek greater independence from glasses for intermediate and/or near distances. It is an aspheric (aberration-neutral) IOL made of hydrophobic acrylic material, coated with heparin with modified C-loop haptics. | Device | Bilateral implantation of investigational device |
Primary outcome
Mean monocular best-corrected distance visual acuity (CDVA)
Time frame: Three (3) Months
The objective is to evaluate Corrected Distance Visual Acuity (CDVA)
1 secondary outcome
Refractive Predictability / Manifest Refraction and Prediction Error
Time frame: Twelve (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 22 Jul 2026.
- 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AT ELANA in people with Cataract and Refractive Lens Exchange, run by Carl Zeiss Meditec AG at 3 sites in 2 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 6 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Spain. 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 best-corrected distance visual acuity (CDVA) (time frame: Three (3) 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 22 Jul 2026.