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

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

Sponsors

Lead Sponsor: South Tyneside and Sunderland NHS Foundation Trust

Source 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.

Overall Status Not yet recruiting
Start Date March 1, 2021
Completion Date September 1, 2023
Primary Completion Date March 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Recruitment rate From the start to the end of the 10 month planned recruitment period
Secondary Outcome
Measure Time Frame
Retinal thickness on SD OCT Between baseline and day 40
Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40 Between baseline and day 40
Enrollment 70
Condition
Intervention

Intervention Type: Device

Intervention Name: Centurion Phacoemulsification System

Description: Infusion Pressure

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
David Steel Principal Investigator South Tyneside and Sunderland NHS Trust
Overall Contact

Last Name: Steve Dodds

Phone: +441915699039

Email: [email protected]

Verification Date

October 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard pressure

Type: Active Comparator

Description: Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg

Label: Low or physiological pressure

Type: Active Comparator

Description: Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg

Acronym ENHANSE
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking Description: All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.

Source: ClinicalTrials.gov