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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) IOP 28mmHg on the better eye and IOP 50mmHg on the worse eye | Other | Near normal intraocular pressure cataract surgery using active anterior chamber pressure sensing and regulation |
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| B) IOP 28mmHg on worse eye and IOP 50mmHg on the better eye | Other | Near normal intraocular pressure cataract surgery using active anterior chamber pressure sensing and regulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation | Device | Cataract surgery in patients with diabetic retinopathy using active anterior chamber pressure sensing and regulation |
| Measure | Description | Time Frame |
|---|---|---|
| Delta ACF | Difference from pre- to postoperative ACF (delta ACF) at day 1 (FU1) and day 7 (FU2) after cataract surgery. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA | Difference between pre- to postoperative BCVA | 1 month |
| 5mm corneal volume | Pentacam derived | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck, University Hospital for Ophthalmology and Optometry | Innsbruck | 6020 | Austria |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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controlled randomized, comparative
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| Anterior chamber depth | Pentacam derived | 1 month |
| Mydriatic pupil width | Pentacam derived | 1 month |
| Endothelial cell density | Quantifying assessment of endothelial cell loss via specular microscopy; (28 +-3) days after surgery. | 1 month |
| Assessment of intraoperative complications | Screening for the presence of posterior capsular ruptures | 1 month |
| Assessment of postoperative complications | Presence of cystoid macular edema | 1 month |
| Intraoperative events | Assessment of any event in regard to phacoemulsification settings | Day 0 (Surgery) |
| Central macular thickness | Pre- and postoperative assessment of central macular thickness via optical coherence tomography (OCT) | 1 month |
| Total macular volume | Pre- and postoperative assessment of total macular volume via optical coherence tomography (OCT) | 1 month |
| Retinal Nerver fiber layer thickness (RNFL) | Pre- and postoperative assessment of RNFL via optical coherence tomography (OCT) | 1 month |
| Central corneal thickness | Pre- and postoperative assessment of central corneal thickness via optical coherence tomography (OCT) | 1 month |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007905 | Lens Diseases |