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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

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.

Condition or disease Intervention/treatment Phase
Glaucoma Diagnostic Test: SITA FAST VISUAL FIELD TEST Diagnostic Test: SITA STANDARD VISUAL FIELD TEST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Official Title: Specificity and Patient Perception of SITA-Standard Compared to SITA-Fast Visual Fields in Patients Suspected of Having Glaucoma
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
SITA FAST then SITA STANDARD
SITA FAST and SITA STANDARD
Diagnostic Test: SITA FAST VISUAL FIELD TEST
Diagnostic test for glaucoma

Diagnostic Test: SITA STANDARD VISUAL FIELD TEST
Diagnostic test for glaucoma

Active Comparator: SITA STANDARD then SITA FAST
SITA FAST and SITA STANDARD
Diagnostic Test: SITA FAST VISUAL FIELD TEST
Diagnostic test for glaucoma

Diagnostic Test: SITA STANDARD VISUAL FIELD TEST
Diagnostic test for glaucoma




Primary Outcome Measures :
  1. specificity of the visual field tests [ Time Frame: 1 year ]
    specificity


Secondary Outcome Measures :
  1. Patients' rating of test difficulty [ Time Frame: 1 year ]
    number

  2. The number of "questions asked" (number of presented stimuli). [ Time Frame: 1 year ]
    number



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192085


Contacts
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Contact: michael Smith, MBCHB +44 (0)1392-406316 Michael.smith26@nhs.net

Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
University of Exeter
University of Plymouth
Investigators
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Principal Investigator: Michael Smith, MBChB Royal Devon

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Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03192085     History of Changes
Other Study ID Numbers: MS/22/02/17
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases