Clinical trial NCT04252716: VISPER: Randomised Comparison of Two OVDs in Cataract Surgery
Official title: Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 273
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in need of cataract surgery

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


Eligibility criteria: 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.)

Primary outcomes:
measure: IOP
timeFrame: 6-hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University hospital Freiburg
state: Baden-Württemberg
Study officials:
References: