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NCT04037631 Clinical Trial

Compare Visual Outcomes Using a New Diagnostic Device

Presbyopia Clinical Trial

Official title:
Prospective Clinical Study to Compare Visual Performance Obtained With a New Diagnostic Device

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04037631
Other study ID # AT-LISA-tri 839MP BER-401-17
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 20, 2017
Est. completion date May 1, 2020

Study information
Verified date January 2021
Source Carl Zeiss Meditec AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of preoperative corrected distance visual acuity (CDVA) obtained with VirtIOL device compared to postoperative CDVA.

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Diagnostic device
Diagnostic test

Locations
Country Name City State
Germany Internationale Innovative Ophthalmologie Düsseldorf

Sponsors (1)
Lead Sponsor Collaborator
Carl Zeiss Meditec AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corrected distance visual acuity (CDVA) Evaluation of CDVA obtained with diagnostic device 3 months after surgery
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