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


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Verified June 2017 by Royal Devon and Exeter NHS Foundation Trust

Sponsor:

Collaborators:

University of Exeter

University of Plymouth

Information provided by (Responsible Party):

Royal Devon and Exeter NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03192085

First received: June 12, 2017

Last updated: June 15, 2017

Last verified: June 2017

This study will compare SITA-Standard and SITA-Fast tests in patients newly referred to the glaucoma screening clinic at the RD&E hospital.

Glaucoma Diagnostic Test: SITA FAST VISUAL FIELD TEST
Diagnostic Test: SITA STANDARD VISUAL FIELD TEST

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Randomised crossover trial of diagnostic test with assessment of comparative accuracy – feasibility study.

Masking: 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

Primary Outcome Measures:

  • specificity of the visual field tests [ Time Frame: 1 year ]

    specificity

Secondary Outcome Measures:

  • Patients’ rating of test difficulty [ Time Frame: 1 year ]

    number

  • The number of “questions asked” (number of presented stimuli). [ Time Frame: 1 year ]

    number

Estimated Enrollment: 150
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
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

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.

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

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03192085

Royal Devon and Exeter NHS Foundation Trust

University of Exeter

University of Plymouth

Principal Investigator: Michael Smith, MBChB Royal Devon

Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03192085     History of Changes
Other Study ID Numbers: MS/22/02/17
Study First Received: June 12, 2017
Last Updated: June 15, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:

Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 19, 2017