VISPER: Randomised Comparison of Two OVDs in Cataract Surgery (VISPER)

Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc

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

Study Overview

• Status: Completed
• Conditions: Cataract Senile
• Intervention / Treatment: Device: OVD

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Freiburg, Baden-Württemberg, Germany, 79106
      • University Hospital Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in need of cataract surgery

Description

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
11. Patients who have previously undergone cataract surgery in the contralateral eye
12. Patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain
13. VISTHESIA (topical and intracameral components) or ProVisc is not a suitable device for the patient for any reason
14. Patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log)
15. Female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery
16. Patients who may require the use of hyaluronidase as part of the study cataract procedure
17. Patients who may be regarded as being vulnerable (e.g. prisoners, residents of care or mental health institutions, trauma, war or disaster victims, dependent on the investigator etc.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VISTHESIA 1.5; Ophtalmologic surgery supported by Visthesia OVD	Device: OVD; Intraocular administration
ProVisc; Ophtalmologic surgery supported by Provisc OVD	Device: OVD; Intraocular administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IOP	Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg	6-hours post-operatively

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2020
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Visth 1.5 BER-401-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No