Compare Visual Outcomes Using a New Diagnostic Device
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ClinicalTrials.gov Identifier: NCT04037631 |
Recruitment Status :
Terminated
(recruitment)
First Posted : July 30, 2019
Last Update Posted : January 28, 2021
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Condition or disease | Intervention/treatment |
---|---|
Presbyopia | Diagnostic Test: Diagnostic device |
Study Type : | Observational |
Actual Enrollment : | 24 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Prospective Clinical Study to Compare Visual Performance Obtained With a New Diagnostic Device |
Actual Study Start Date : | July 20, 2017 |
Actual Primary Completion Date : | May 1, 2020 |
Actual Study Completion Date : | May 1, 2020 |
Group/Cohort | Intervention/treatment |
---|---|
Patients without clinically significant age-related cataract |
Diagnostic Test: Diagnostic device
Diagnostic test |
- Corrected distance visual acuity (CDVA) [ Time Frame: 3 months after surgery ]Evaluation of CDVA obtained with diagnostic device

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037631
Germany | |
Internationale Innovative Ophthalmologie | |
Düsseldorf, Germany, 40549 |
Responsible Party: | Carl Zeiss Meditec AG |
ClinicalTrials.gov Identifier: | NCT04037631 |
Other Study ID Numbers: |
AT-LISA-tri 839MP BER-401-17 |
First Posted: | July 30, 2019 Key Record Dates |
Last Update Posted: | January 28, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Presbyopia Refractive Errors Eye Diseases |