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Femtosecond Laser Assisted Cataract Surgery in The NHS

Primary Purpose

Cataract, Surgery

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional cataract surgery (phacoemulsification)
Femtosecond laser assisted cataract surgery
Sponsored by
Guy's and St Thomas' 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 SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
  • Patients must be willing to attend for follow-up at 1 month after cataract surgery.
  • Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.

Exclusion Criteria:

  • Children below the age of 18
  • Already enrolled in another study

The principle exclusion criteria relate to clinical contraindications for FLACS, such as:

  • Significant corneal opacities
  • Small pupils following pharmacological dilatation
  • Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Femtosecond laser cataract surgery

    Conventional phacoemulsification surgery

    Arm Description

    Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation

    Conventional phacoemulsification surgery

    Outcomes

    Primary Outcome Measures

    Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
    These include (but not necessarily be limited to) the cost of surgery for both arms of the trial (including resource use and staffing levels required for the surgical protocols), resource use attributable to managing complications arising from surgery, all relevant diagnostic investigations, further surgery where necessary, hospital length of stay and ward type, outpatient attendances, procedures performed on an outpatient basis, Accident & Emergency attendances and prescribed drug medications. The quantity of resource use for each cost component will be measured from medical records. Site-specific unit costs will be taken in preference of standard published sources or national tariffs where possible.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 20, 2016
    Last Updated
    July 22, 2020
    Sponsor
    Guy's and St Thomas' NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02825693
    Brief Title
    Femtosecond Laser Assisted Cataract Surgery in The NHS
    Official Title
    The Development of Surgical Pathways Using Femto-second Laser Technology to Increase the Efficiency and Safety of Cataract Surgery Within a Public Health Sector Setting - A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guy's and St Thomas' NHS Foundation Trust

    4. Oversight

    5. Study Description

    Brief Summary
    This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Femtosecond laser cataract surgery
    Arm Type
    Active Comparator
    Arm Description
    Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation
    Arm Title
    Conventional phacoemulsification surgery
    Arm Type
    Active Comparator
    Arm Description
    Conventional phacoemulsification surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional cataract surgery (phacoemulsification)
    Intervention Type
    Procedure
    Intervention Name(s)
    Femtosecond laser assisted cataract surgery
    Primary Outcome Measure Information:
    Title
    Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
    Description
    These include (but not necessarily be limited to) the cost of surgery for both arms of the trial (including resource use and staffing levels required for the surgical protocols), resource use attributable to managing complications arising from surgery, all relevant diagnostic investigations, further surgery where necessary, hospital length of stay and ward type, outpatient attendances, procedures performed on an outpatient basis, Accident & Emergency attendances and prescribed drug medications. The quantity of resource use for each cost component will be measured from medical records. Site-specific unit costs will be taken in preference of standard published sources or national tariffs where possible.
    Time Frame
    up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms. Patients must be willing to attend for follow-up at 1 month after cataract surgery. Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires. Exclusion Criteria: Children below the age of 18 Already enrolled in another study The principle exclusion criteria relate to clinical contraindications for FLACS, such as: Significant corneal opacities Small pupils following pharmacological dilatation Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.

    12. IPD Sharing Statement

    Learn more about this trial

    Femtosecond Laser Assisted Cataract Surgery in The NHS

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