VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

NCT04252716 | Completed

• 1 other identifier: Visth 1.5 BER-401-19
• Study Type: observational
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• IOP

  Frequency of incidence of Intraocular Pressure greater than or equal to 30 mm Hg

  6-hours post-operatively

Study Arms (2)

VISTHESIA 1.5

Ophtalmologic surgery supported by Visthesia OVD

Device: OVD

ProVisc

Ophtalmologic surgery supported by Provisc OVD

Device: OVD

Interventions

OVD DEVICE

Intraocular administration

ProVisc; VISTHESIA 1.5

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in need of cataract surgery

You may qualify if:

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

You may not qualify if:

• Patients not able to / willing to give informed consent
• Patients not able to comprehend and comply with study requirements
• Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed)
• Patients not able to attend follow-up appointments for any reason
• Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan
• Patients with reduced corneal endothelium (e.g. Fuch's dystrophy)
• Patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function
• Patients being treated with tocainide for cardiac arrhythmia
• Patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels
• Mono-ophthalmic patients
• Patients who have previously undergone cataract surgery in the contralateral eye
• Patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain
• VISTHESIA (topical and intracameral components) or ProVisc is not a suitable device for the patient for any reason
• Patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log)
• Female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

University hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: September 24, 2020
• Primary Completion: November 24, 2021
• Study Completion: February 8, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

DE (1)