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Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SITA FAST VISUAL FIELD TEST
SITA STANDARD VISUAL FIELD TEST
Sponsored by
Royal Devon and Exeter NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma.

Exclusion Criteria:

  • 1. Patients who are unable to perform visual field tests. 2. Patients who are unable to have a full glaucoma assessment. 3. Patients who have undertaken visual field tests in hospital eye departments in the last 2 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    SITA FAST then SITA STANDARD

    SITA STANDARD then SITA FAST

    Arm Description

    SITA FAST and SITA STANDARD

    SITA FAST and SITA STANDARD

    Outcomes

    Primary Outcome Measures

    specificity of the visual field tests
    specificity

    Secondary Outcome Measures

    Patients' rating of test difficulty
    number
    The number of "questions asked" (number of presented stimuli).
    number

    Full Information

    First Posted
    June 12, 2017
    Last Updated
    June 15, 2017
    Sponsor
    Royal Devon and Exeter NHS Foundation Trust
    Collaborators
    University of Exeter, University of Plymouth
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03192085
    Brief Title
    Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.
    Official Title
    Specificity and Patient Perception of SITA-Standard Compared to SITA-Fast Visual Fields in Patients Suspected of Having Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Royal Devon and Exeter NHS Foundation Trust
    Collaborators
    University of Exeter, University of Plymouth

    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
    This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD&E hospital.
    Detailed Description
    This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD&E hospital. In addition to standard care (SITA-Fast) each person who agrees to take part in the trial will undertake one extra visual field test (SITA-Standard). By comparing the results of the two types of visual field test the investigators aim to provide information on which of the two tests is more specific for glaucoma and which test is better tolerated by patients. The investigators anticipate that this study will generate sufficient data to support a grant application for a longitudinal study to examine the relative merits of different visual field tests in patients with glaucoma and those suspected of developing the disease.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SITA FAST then SITA STANDARD
    Arm Type
    Other
    Arm Description
    SITA FAST and SITA STANDARD
    Arm Title
    SITA STANDARD then SITA FAST
    Arm Type
    Active Comparator
    Arm Description
    SITA FAST and SITA STANDARD
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    SITA FAST VISUAL FIELD TEST
    Intervention Description
    Diagnostic test for glaucoma
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    SITA STANDARD VISUAL FIELD TEST
    Intervention Description
    Diagnostic test for glaucoma
    Primary Outcome Measure Information:
    Title
    specificity of the visual field tests
    Description
    specificity
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Patients' rating of test difficulty
    Description
    number
    Time Frame
    1 year
    Title
    The number of "questions asked" (number of presented stimuli).
    Description
    number
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma. Exclusion Criteria: 1. Patients who are unable to perform visual field tests. 2. Patients who are unable to have a full glaucoma assessment. 3. Patients who have undertaken visual field tests in hospital eye departments in the last 2 years.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    michael Smith, MBCHB
    Phone
    +44 (0)1392-406316
    Email
    Michael.smith26@nhs.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Smith, MBChB
    Organizational Affiliation
    Royal Devon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.

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