VISPER: Randomised Comparison of Two OVDs in Cataract Surgery

Inclusion criteria

• Patients of any gender, 50 years of age or older at the time of study enrolment
• undergoing age-related cataract removal (phacoemulsification) and IOL implantation in one eye only
• Patient informed of the needs and visit schedule required of the Clinical Investigational Plan and who has given his/her written informed consent
• Planned implantation of the IOL in the capsular bag

Exclusion criteria

• Patients not able to / willing to give informed consent
• Patients not able to comprehend and comply with study requirements
• Patients scheduled for surgery to the fellow eye within 48 hrs preceding any scheduled study follow up. (Surgery date could be changed)
• Patients not able to attend follow-up appointments for any reason
• Patients with known hypersensitivity to anaesthetics of the amide type or hyaluronan
• Patients with reduced corneal endothelium (e.g. Fuch's dystrophy)
• Patients with epilepsy, impaired cardiac conduction, bradycardia, or impaired respiratory function
• Patients being treated with tocainide for cardiac arrhythmia
• Patients with impaired hepatic function, if the anaesthetic dose or site of application is likely to result in high blood levels
• Mono-ophthalmic patients
• Patients who have previously undergone cataract surgery in the contralateral eye
• Patients with any psychosocial, or other chronic disease conditions that may affect the perception of bodily pain
• VISTHESIA (topical and intracameral components) or ProVisc is not a suitable device for the patient for any reason
• Patients with other pathology or condition presenting, according to the investigator opinion, a risk for the patient (to be documented in screen log)
• Female patients who are menstruating, pregnant, breastfeeding or amenorrheic for less than 2 years at the time of surgery
• Patients who may require the use of hyaluronidase as part of the study cataract procedure
• 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.)