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

Not Applicable

• Conditions: Cataract
• Interventions: Device: Centurion Phacoemulsification System

• Registration Number: NCT04637685
• Lead Sponsor: South Tyneside and Sunderland NHS Foundation Trust

Brief Summary

The effect of infusion pressure on the outcomes of phacoemulsification surgery.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-11-16
• Last Update Submitted: 2020-11-16
• Study First Posted: 2020-11-20
• Last Update Posted: 2020-11-20
• Study Start: 2021-03-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard pressure	Centurion Phacoemulsification System	Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg
Low or physiological pressure	Centurion Phacoemulsification System	Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg

Primary Outcome Measures

Name	Time	Method
Recruitment rate	From the start to the end of the 10 month planned recruitment period	The study has been designed as a feasibility study to assess recruitment rate. We will measure rate of recruitment to study (persons per month)

Secondary Outcome Measures

Name	Time	Method
Retinal thickness on SD OCT	Between baseline and day 40	The above will be measured preoperatively and compared with day 40
Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40	Between baseline and day 40	The above will be measured preoperatively and compared with day 40