Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617273
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Cataract Surgery with Near Normal Eye Pressure in Patients with Diabetic Retinopathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NNIOP-PHACO
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None