The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study (ENHANSE)
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Centurion Phacoemulsification System
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard pressure
Low or physiological pressure
Arm Description
Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg
Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Retinal thickness on SD OCT
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
The above will be measured preoperatively and compared with day 40
Full Information
NCT ID
NCT04637685
First Posted
October 7, 2020
Last Updated
November 16, 2020
Sponsor
South Tyneside and Sunderland NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04637685
Brief Title
The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study
Acronym
ENHANSE
Official Title
The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Tyneside and Sunderland NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard pressure
Arm Type
Active Comparator
Arm Description
Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg
Arm Title
Low or physiological pressure
Arm Type
Active Comparator
Arm Description
Infusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg
Intervention Type
Device
Intervention Name(s)
Centurion Phacoemulsification System
Intervention Description
Infusion Pressure
Primary Outcome Measure Information:
Title
Recruitment rate
Description
The study has been designed as a feasibility study to assess recruitment rate. We will measure rate of recruitment to study (persons per month)
Time Frame
From the start to the end of the 10 month planned recruitment period
Secondary Outcome Measure Information:
Title
Retinal thickness on SD OCT
Description
The above will be measured preoperatively and compared with day 40
Time Frame
Between baseline and day 40
Title
Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40
Description
The above will be measured preoperatively and compared with day 40
Time Frame
Between baseline and day 40
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Dodds
Phone
+441915699039
Email
steven.dodds@chsft.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
David Steel
Phone
+441915656256
Email
david.steel@chsft.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Steel
Organizational Affiliation
South Tyneside and Sunderland NHS Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery; the ENHANSE Study
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