This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Cataract Senile

VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

Sponsored by Carl Zeiss Meditec AG

About this trial

Last updated 2 years ago

Study ID

Visth 1.5 BER-401-19

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
50+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial 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

What are the participation requirements?

Yes

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

No

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.)

Locations

Location

Status