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

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ClinicalTrials.gov Identifier: NCT03192085
Recruitment Status : Unknown
Verified June 2017 by Royal Devon and Exeter NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2017
Last Update Posted : June 19, 2017
Sponsor:
Collaborators:
University of Exeter
University of Plymouth
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE June 12, 2017
First Posted Date  ICMJE June 19, 2017
Last Update Posted Date June 19, 2017
Estimated Study Start Date  ICMJE July 2017
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
specificity of the visual field tests [ Time Frame: 1 year ]
specificity
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
  • Patients' rating of test difficulty [ Time Frame: 1 year ]
    number
  • The number of "questions asked" (number of presented stimuli). [ Time Frame: 1 year ]
    number
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.
Official Title  ICMJE Specificity and Patient Perception of SITA-Standard Compared to SITA-Fast Visual Fields in Patients Suspected of Having Glaucoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • Diagnostic Test: SITA FAST VISUAL FIELD TEST
    Diagnostic test for glaucoma
  • Diagnostic Test: SITA STANDARD VISUAL FIELD TEST
    Diagnostic test for glaucoma
Study Arms  ICMJE
  • SITA FAST then SITA STANDARD
    SITA FAST and SITA STANDARD
    Interventions:
    • Diagnostic Test: SITA FAST VISUAL FIELD TEST
    • Diagnostic Test: SITA STANDARD VISUAL FIELD TEST
  • Active Comparator: SITA STANDARD then SITA FAST
    SITA FAST and SITA STANDARD
    Interventions:
    • Diagnostic Test: SITA FAST VISUAL FIELD TEST
    • Diagnostic Test: SITA STANDARD VISUAL FIELD TEST
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 15, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192085
Other Study ID Numbers  ICMJE MS/22/02/17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Royal Devon and Exeter NHS Foundation Trust
Study Sponsor  ICMJE Royal Devon and Exeter NHS Foundation Trust
Collaborators  ICMJE
  • University of Exeter
  • University of Plymouth
Investigators  ICMJE
Principal Investigator: Michael Smith, MBChB Royal Devon
PRS Account Royal Devon and Exeter NHS Foundation Trust
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP