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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Centurion Phacoemulsification System

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steve Dodds; Phone Number: +441915699039; Email: steven.dodds@chsft.nhs.uk
• Study Contact Backup: Name: David Steel; Phone Number: +441915656256; Email: david.steel@chsft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: South Tyneside and Sunderland NHS Foundation Trust
• Investigators: Principal Investigator: David Steel, South Tyneside and Sunderland NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 288743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No