VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

Sponsor
Carl Zeiss Meditec AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04252716
Collaborator
(none)
268
1
15.6
17.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: OVD

Study Design

Study Type:
Observational
Anticipated Enrollment :
268 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Prospective, Randomized, Multi-centre, Observer-masked, Non-inferiority Comparison of Two Cohesive Viscoelastic Solutions: VISTHESIA v Provisc
Actual Study Start Date :
Aug 12, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. IOP [6-hours post-operatively]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University hospital Freiburg Freiburg Baden-Württemberg Germany 79106

Sponsors and Collaborators

  • Carl Zeiss Meditec AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Carl Zeiss Meditec AG
ClinicalTrials.gov Identifier:
NCT04252716
Other Study ID Numbers:
  • Visth 1.5 BER-401-19
First Posted:
Feb 5, 2020
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2020