The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study

Study Overview
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Brief Summary
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The effect of infusion pressure on the outcomes of phacoemulsification surgery.

Detailed Description
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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.

Official Title
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The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery

Conditions
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Cataract

Intervention / Treatment
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* Device: Centurion Phacoemulsification System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree Exclusion Criteria: Dense cataract precluding adequate retinal imaging posterior polar cataract subluxated cataract, other vision affecting pathology, severe glaucoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard pressure<br>Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg | Device: Centurion Phacoemulsification System<br>* Infusion Pressure<br>|
| Active Comparator: Low or physiological pressure<br>Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg | Device: Centurion Phacoemulsification System<br>* Infusion Pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | The above will be measured preoperatively and compared with day 40 | Between baseline and day 40 |