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Compare Visual Outcomes Using a New Diagnostic Device

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ClinicalTrials.gov Identifier: NCT04037631
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec AG

Study Description
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Brief Summary:
Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.

Condition or disease Intervention/treatment
Presbyopia Diagnostic Test: Diagnostic device

Study Design
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Study Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients without clinically significant age-related cataract Diagnostic Test: Diagnostic device
Diagnostic test


Outcome Measures
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Primary Outcome Measures :
  1. Corrected distance visual acuity (CDVA) [ Time Frame: 3 months after surgery ]
    Evaluation of CDVA obtained with diagnostic device


Eligibility Criteria
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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
Study Population
Patients without clinically significant age-related cataract
Criteria

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

  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: CZM CA +49308540010 clinicalstudies.meditec.sur@zeiss.com

Locations
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Germany
Internationale Innovative Ophthalmologie Recruiting
Düsseldorf, Germany, 40549
Contact: Hakan Kaymak    0211 586757-0      
Sponsors and Collaborators
Carl Zeiss Meditec AG
More Information
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Responsible Party: Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier: NCT04037631     History of Changes
Other Study ID Numbers: AT-LISA-tri 839MP BER-401-17
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases