Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery

Exclusion Criteria

• •1. Any acute, chronic or uncontrolled disease as severe heart failure, recent cardiovascular event, respiratory failure, severe hepatic or renal disease, poorly controlled diabetes mellitus, active severe autoimmune disease, active malignancy etc. that in the opinion of the Investigator, would increase the risk of operation or affect the outcome of the study;
• •2. Epilepsy and any other condition that would prevent cooperation during surgery, including head tremor, deafness, neck or back problems, restless legs syndrome, claustrophobia etc.;
• •3. Have a history of allergic/hypersensitivity reaction to sodium hyaluronate (NaHA);
• •4. Participation in another clinical trial within the past 30 days;
• •The following criteria apply both eyes:
• •1. Corneal endothelium cell density less than 1800 cells/mm square;
• •2. Pseudoexfoliation syndrome (PEX) or suspected zonular compromise of any origin;
• •3. Corneal angle narrow or/and glaucoma;
• •4. Anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation etc.);
• •5. Any corneal irregularity or leukoma (as assessed by slit lamp and specular microscope pachymetry);
• •6. Complicated cataracts;
• •7. Subjects requiring implantation of toric lenses;
• •8. Proliferative retinopathy, macular degeneration or oedema of any origin. Other ocular pathology that may compromise vision despite successful cataract surgery;
• •9. Signs of ocular or systemic infection and/or inflammation;
• •10. Previous intraocular surgery, refractive surgery or severe ocular trauma.