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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Cataract surgery in patients with diabetic retinopathy using active anterior chamber pressure sensing and regulation
Medical University Innsbruck, University Hospital for Ophthalmology and Optometry
Innsbruck, Austria
Delta ACF
Difference from pre- to postoperative ACF (delta ACF) at day 1 (FU1) and day 7 (FU2) after cataract surgery.
Time frame: 1 week
BCVA
Difference between pre- to postoperative BCVA
Time frame: 1 month
5mm corneal volume
Pentacam derived
Time frame: 1 month
Anterior chamber depth
Pentacam derived
Time frame: 1 month
Mydriatic pupil width
Pentacam derived
Time frame: 1 month
Endothelial cell density
Quantifying assessment of endothelial cell loss via specular microscopy; (28 +-3) days after surgery.
Time frame: 1 month
Assessment of intraoperative complications
Screening for the presence of posterior capsular ruptures
Time frame: 1 month
Assessment of postoperative complications
Presence of cystoid macular edema
Time frame: 1 month
Intraoperative events
Assessment of any event in regard to phacoemulsification settings
Time frame: Day 0 (Surgery)
Central macular thickness
Pre- and postoperative assessment of central macular thickness via optical coherence tomography (OCT)
Time frame: 1 month
Total macular volume
Pre- and postoperative assessment of total macular volume via optical coherence tomography (OCT)
Time frame: 1 month
Retinal Nerver fiber layer thickness (RNFL)
Pre- and postoperative assessment of RNFL via optical coherence tomography (OCT)
Time frame: 1 month
Central corneal thickness
Pre- and postoperative assessment of central corneal thickness via optical coherence tomography (OCT)
Time frame: 1 month
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