VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

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.)