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VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

NCT04252716 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 273

Last updated 2023-03-15

No results posted yet for this study

Summary

To investigate that VISTHESIA 1.5 is non-inferior to Provisc with regards to elevation in IOP greater than or equal to 30 mm Hg 6 ± 2 hours post-operatively as per methodology set out in EN ISO 15798:2013 (Primary Endpoint) To compare the changes in endothelial cell count and incidences of intraocular inflammation between VISTHESIA and Provisc as per methodology set out in EN ISO 15798:2013

Conditions

  • Cataract Senile

Interventions

DEVICE

OVD

Intraocular administration

Sponsors & Collaborators

  • Carl Zeiss Meditec AG

    lead INDUSTRY

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2021-11-24
Completion
2022-02-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04252716 on ClinicalTrials.gov