Trials / Completed
CompletedNCT04252716
VISPER: Randomised Comparison of Two OVDs in Cataract Surgery
Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 273 (actual)
- Sponsor
- Carl Zeiss Meditec AG · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OVD | Intraocular administration |
Timeline
- Start date
- 2020-09-24
- Primary completion
- 2021-11-24
- Completion
- 2022-02-08
- First posted
- 2020-02-05
- Last updated
- 2023-03-15
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04252716. Inclusion in this directory is not an endorsement.