Compare Visual Outcomes Using a New Diagnostic Device

January 26, 2021 updated by: Carl Zeiss Meditec AG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40549
        • Internationale Innovative Ophthalmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients without clinically significant age-related cataract

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients without clinically significant age-related cataract
Diagnostic test: Diagnostic device
Diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corrected distance visual acuity (CDVA)
Time Frame: 3 months after surgery
Evaluation of CDVA obtained with diagnostic device
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carl Zeiss Meditec AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2017

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-LISA-tri 839MP BER-401-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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