Clinical Research Directory

Inclusion Criteria: 1. Indication for immediate sequential bilateral microincision cataract surgery 2. Diagnosis of Diabetes Mellitus treated with oral medication or insulin therapy and confirmed by HbA1c ≥6,5 % 3. Presence of diabetic retinopathy grade ≥1 on the international clinical diabetic retinopathy (ICDR) severity scale 4. LOCS 2-4 with no more than 1 grade difference between both eyes 5. Male or female patient aged 50 - 85 years of age at time of consent 6. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature Exclusion Criteria: 1. Participation in another clinical trial within 30 days before pre-screening and throughout the trial 2. Prior intraocular surgery of any type 3. History of diabetic macular edema 4. Presence of macular edema, defined as central retinal thickness of \>300 µm plus intraretinal or subretinal fluid on OCT within range of 1mm of foveal center 5. Presence of any retinal or choroidal disease, other than diabetes, that could affect retinal thickness 6. Known history of uveitis 7. Documented use of systemic or topical steroid or other immunosuppressive medication within the last 3 months 8. ACF \>10 ph/ms. ACF difference between right and left eye \> 4ph/ms 9. Difference of DRP grading between right and left eye of more than 1 grade (ICDR) 10. Inability to measure total macular volume due to, but not limed to, too dense cataract, vitreous bleeding 11. Woman of childbearing potential (WOCBP) who is breastfeeding, has a positive urine pregnancy test, is not willing to undergo a urine pregnancy test upon entering or exiting the study, intends to become pregnant during the study, or does not agree to use adequate birth control methods for the duration of the study 12. Patients in possession of an active implantable medical device (AIMD)