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
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
The effect of infusion pressure on the outcomes of phacoemulsification surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedNovember 20, 2020
October 1, 2020
2 years
October 7, 2020
November 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Standard pressure
ACTIVE COMPARATORInfusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 70mmHg
Low or physiological pressure
ACTIVE COMPARATORInfusion pressures during phacoemulsification surgeon using the Alcon active sentry system with the Centurion - 30mmHg
Interventions
Infusion Pressure
Eligibility Criteria
You may qualify if:
- Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree
You may not qualify if:
- Dense cataract precluding adequate retinal imaging
- posterior polar cataract
- subluxated cataract,
- other vision affecting pathology,
- severe glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Steel
South Tyneside and Sunderland NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
November 20, 2020
Study Start
March 1, 2021
Primary Completion
March 1, 2023
Study Completion
September 1, 2023
Last Updated
November 20, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share