VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

NCT ID: NCT04252716

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 273 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-24
• Study Completion Date: 2022-02-08

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

VISTHESIA 1.5

Ophtalmologic surgery supported by Visthesia OVD

OVD

Intervention Type: DEVICE

Intraocular administration

ProVisc

Ophtalmologic surgery supported by Provisc OVD

OVD

Intervention Type: DEVICE

Intraocular administration

Interventions

OVD

Intraocular administration

Intervention Type: DEVICE

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.)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carl Zeiss Meditec AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

Visth 1.5 BER-401-19

Identifier Type: -

Identifier Source: org_study_id