VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

Carl Zeiss Meditec

Status

Completed

Conditions

Cataract Senile

Treatments

Device: OVD

Study type

Observational

Funder types

Industry

Identifiers

NCT04252716

Visth 1.5 BER-401-19

Details and patient eligibility

About

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

Enrollment

273 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Patients who may require the use of hyaluronidase as part of the study cataract procedure
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.)