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VISPER: Randomised Comparison of Two OVDs in Cataract Surgery | Clinical Trials | Clareo Health

COMPLETED

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

NCT04252716•Carl Zeiss Meditec AG

View on ClinicalTrials.gov

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

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients of any gender, 50 years of age or older at the time of study enrolment
•2. undergoing age-related cataract removal (phacoemulsification) and IOL implantation in one eye only
•3. Patient informed of the needs and visit schedule required of the Clinical Investigational Plan and who has given his/her written informed consent
•4. Planned implantation of the IOL in the capsular bag

Exclusion Criteria

•1. Patients not able to / willing to give informed consent
•2. Patients not able to comprehend and comply with study requirements
•3. Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed)
•4. Patients not able to attend follow-up appointments for any reason
•5. Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan
•6. Patients with reduced corneal endothelium (e.g. Fuch's dystrophy)
•7. Patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function
•8. Patients being treated with tocainide for cardiac arrhythmia
•9. Patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels
•10. Mono-ophthalmic patients
+7 more criteria

Locations (1)

University hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Key Dates

Start Date

September 24, 2020

Primary Completion Date

November 24, 2021

Completion Date

February 8, 2022

Last Updated

March 15, 2023

Enrollment

273

ACTUAL participants

Conditions

Cataract Senile

Interventions

OVD

DEVICE

Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement

NCT04570579

CataractCataract Senile+1 more

View study

COMPLETEDNA

Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction

NCT06483750

Dry Eye DiseaseMeibomian Gland Dysfunction+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

Inclusion Criteria

Exclusion Criteria

Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement

Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction

Evaluation of Glistening, Visual Outcomes and General Safety 24 Months Post-IOL Implantation

Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis

The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study

Ocular Coherence Tomography During Cataract Assessment