Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.
June 15, 2017 updated by: Royal Devon and Exeter NHS Foundation Trust
Specificity and Patient Perception of SITA-Standard Compared to SITA-Fast Visual Fields in Patients Suspected of Having 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: SITA FAST then SITA STANDARD
SITA FAST and SITA STANDARD
|
Diagnostic test for glaucoma
Diagnostic test for glaucoma
|
|
Active Comparator: SITA STANDARD then SITA FAST
SITA FAST and SITA STANDARD
|
Diagnostic test for glaucoma
Diagnostic test for glaucoma
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
specificity of the visual field tests
Time Frame: 1 year
|
specificity
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' rating of test difficulty
Time Frame: 1 year
|
number
|
1 year
|
|
The number of "questions asked" (number of presented stimuli).
Time Frame: 1 year
|
number
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Smith, MBChB, Royal Devon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2017
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
June 12, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 19, 2017
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
June 15, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS/22/02/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.