NCT06617273

Cataract Surgery with Near Normal Eye Pressure in Patients with Diabetic Retinopathy

Near Normal Intraocular Pressure Cataract Surgery in Patients with Diabetic Retinopathy Using Active Anterior Chamber Pressure Sensing and Regulation - a Randomized Controlled Comparative Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Retinopathy
• Cataract

Interventions

Type	Name	Description
DEVICE	Ophthalmosurgical handpiece with active anterior chamber pressure sensing and regulation	Cataract surgery in patients with diabetic retinopathy using active anterior chamber pressure sensing and regulation

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-09-01
• Completion: 2025-09-30
• First posted: 2024-09-27
• Last updated: 2024-09-27

Locations

1 site across 1 country: Austria