PresbyopiaNCT04037631
Compare Visual Outcomes Using a New Diagnostic Device
An observational study of Presbyopia, run by Carl Zeiss Meditec AG at 1 site in Germany.
Trial summary
Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Diagnostic device
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jul 2017to 1 May 2020
- Phase
- Observational
- 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
Study population: Patients without clinically significant age-related cataract
Who may be able to join
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- Patients of any gender, aged 18 years to open age
- Assured follow-up examinations
- Healthy eyes without clinically significant age-related cataract
- -Exclusion Criteria:
- 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 drug or device investigation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Study to Compare Visual Performance Obtained With a New Diagnostic Device
Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.
- Conditions
- Presbyopia
- Being tested
- Diagnostic device
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic deviceDiagnostic test
Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Patients without clinically significant age-related cataract | Not described Receives: Diagnostic Test: Diagnostic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected distance visual acuity (CDVA)
Evaluation of CDVA obtained with diagnostic device
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start20 Jul 2017
- Primary completion1 May 2020
- Study completion1 May 2020
Why it stopped: recruitment
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 PresbyopiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 24 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
- NCT04037631
- Sponsor's protocol ID
- AT-LISA-tri 839MP BER-401-17
- Status last verified
- Jan 2021
- First submitted
- 26 Jul 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schallhorn SC, Fernandez J, Kaymak H, Gerlach M, Kirchner FO. Prediction of visual outcomes using virtual implantation of a trifocal intraocular lens in presbyopic lens exchange patients. J Cataract Refract Surg. 2025 Feb 1;51(2):133-140. doi: 10.1097/j.jcrs.0000000000001576.
PubMed 39453845
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Compare Visual Performance Obtained With a New Diagnostic Device
- ClinicalTrials.gov ID
- NCT04037631
- Acronym / sponsor ID
- AT-LISA-tri 839MP BER-401-17
- Conditions
- Presbyopia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 30 Jul 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.
Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients without clinically significant age-related cataract | – | Diagnostic Test: Diagnostic device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without clinically significant age-related cataract
Key inclusion criteria (8 listed)
- Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent
- Patients of any gender, aged 18 years to open age
- Assured follow-up examinations
- Healthy eyes without clinically significant age-related cataract
- Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diagnostic deviceDiagnostic test | Diagnostic test | Patients without clinically significant age-related cataract |
Primary outcome
Corrected distance visual acuity (CDVA)
Time frame: 3 months after surgery
Evaluation of CDVA obtained with diagnostic device
Results and safety
The study was stopped early (reason given: recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Derived from this study: PubMed 39453845Schallhorn SC, Fernandez J, Kaymak H, Gerlach M, Kirchner FO. Prediction of visual outcomes using virtual implantation of a trifocal intraocular lens in presbyopic lens exchange patients. J Cataract Refract Surg. 2025 Feb 1;51(2):133-140. doi: 10.1097/j.jcrs.0000000000001576.
- 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?
An observational study of Presbyopia, 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 8 inclusion and 0 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: stopped early, as of the sponsor's last update on 28 Jan 2021. 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 was stopped early (reason given: recruitment). Results are not available in the source record.
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?
Corrected distance visual acuity (CDVA) (time frame: 3 months after surgery). 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 NCT04037631, 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 28 Jan 2021.