Diabetes mellitus is a chronic metabolic disease that can lead to visual impairment and eye complications such as diabetic retinopathy and diabetic macular edema. Diabetics are considered a vulnerable patient group for cataract surgery, as microincision phacoemulsification (MICS) in diabetics is associated with a higher risk of postoperative swelling of the macula and cornea (macular or corneal edema). In addition, the ultrasound energy emitted during MICS, high and fluctuating intraocular pressure and the movement of surgical instruments and lens material are the main causes of surgical trauma. The medical device "Centurion Vision System" with the "Active Sentry" handpiece was developed specifically to improve the stability of the anterior chamber during surgery and to enable operations at low, almost normal physiological intraocular pressure settings. The central question of the study is therefore, whether a stable intraocular pressure close to physiological normal conditions (28 mmHg) during surgery can lead to a reduction in surgical trauma. In this prospective and randomized study, patients suffering from diabetes and having a planned bilateral MICS are included in one of two study arms: A) The participant is operated on with an IOP of 28 mm Hg in the better eye and an IOP of 50 mm Hg in the worse eye or B) the participant is operated on with an IOP of 28 mm Hg in the worse eye and an IOP of 50 mm Hg in the better eye.
Age range
50 Years – 85 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Delta ACF
Timeframe: 1 week