A Clinical Investigation of MINIVISC® PLUS 14 mg/ml Fermented Ophthalmic Viscosurgical Device (OVD-F), Used for Cataract Surgery and Implantation of Intraocular Lenses, Glaucoma Surgery, Anterior Segment Surgery and Corneal Transplantation (CGAC)

Korábbi kezelés

• Any previous hypersensitivity reaction to any constituent of the IMD.
• Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial.
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject.

Más betegség

• Ocular hypertension of ≥22 mmHg, after 3 repeated measurements pre-surgery.
• Any other condition or treatment making the subject unsuitable for participation in the clinical investigation, as judged by the Principal Investigator, including but not exclusive to diagnosis of wide-angle glaucoma, severe myopia, uveitis, and physical traits such as a small pupil, an extremely shallow anterior chamber, or a compromised endothelial cell function.

Laborértékek

• An endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively, based on the average of the three cell counts as taken by the Specular Microscope (only in Phase A).

Egyéb

• Pregnant or lactating females.
• Employees of the study site or the sponsor directly involved with the conduct of the investigation, or immediate family members of any such individuals.

• Male or Female, >18 years, in need of ophthalmic surgery for:
  • Cataract
  • Glaucoma surgery
  • Anterior segment trauma or diseases
  • Damaged or diseased cornea
• Able and willing to give informed consent for participation in the investigation.
• For the participation in Phase A of the study, patients that need surgery on one or both eyes will be included. For the participation in Phase B of the study, patients that need surgery on one or both eyes will be included but only one eye can be included in the clinical investigation.