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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
South Tyneside and Sunderland NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 7, 2020
    Last Updated
    November 16, 2020
    Sponsor
    South Tyneside and Sunderland NHS Foundation Trust
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    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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