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The effect of infusion pressure on the outcomes of phacoemulsification surgery.
The Centurion phacoemulsification system with active sentry allows efficient cataract surgery with safe use of high vacuums, whilst allowing low and physiological infusion pressures, significantly lower than other surgical systems. There are reasons to expect that this will lead to patient benefit but it is uncertain if low infusion pressure during phacoemulsification will lead to improved outcomes. This is of particular interest in patients with vascular retinopathies such as diabetic retinopathy where the retinal vasculature is compromised, as well as glaucoma and other optic neuropathies where there is established nerve fibre layer loss.
The investigator will carry out a feasibility study with a two surgeon RCT of 70 patients with diabetic retinopathy and/or glaucoma undergoing phacoemulsification with randomisation of two different infusion pressures (low (30mmHg) versus the higher pressure (~70mmHg) as currently used) using the active sentry system with assessment of a range of exploratory endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard pressure | Active Comparator | Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg |
|
| Low or physiological pressure | Active Comparator | Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centurion Phacoemulsification System | Device | Infusion Pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The study has been designed as a feasibility study to assess recruitment rate. We will measure rate of recruitment to study (persons per month) | From the start to the end of the 10 month planned recruitment period |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal thickness on SD OCT | The above will be measured preoperatively and compared with day 40 | Between baseline and day 40 |
| Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steve Dodds | Contact | +441915699039 | steven.dodds@chsft.nhs.uk | |
| David Steel | Contact | +441915656256 | david.steel@chsft.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| David Steel | South Tyneside and Sunderland NHS Trust | Principal Investigator |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.
The above will be measured preoperatively and compared with day 40
| Between baseline and day 40 |