GlaucomaNCT03192085
Comparison of SITA-Standard Compared to SITA-Fast Visual Fields.
A study testing SITA FAST VISUAL FIELD TEST and SITA STANDARD VISUAL FIELD TEST in people with Glaucoma, run by Royal Devon and Exeter NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- SITA FAST VISUAL FIELD TEST and SITA STANDARD VISUAL FIELD TEST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- SITA FAST VISUAL FIELD TEST, SITA STANDARD VISUAL FIELD TEST
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SITA FAST VISUAL FIELD TESTDiagnostic test
Diagnostic test for glaucoma
SITA STANDARD VISUAL FIELD TESTDiagnostic test
Diagnostic test for glaucoma
| Study group | Role | What they receive |
|---|---|---|
| SITA FAST then SITA STANDARD | Other | SITA FAST and SITA STANDARD Receives: Diagnostic Test: SITA FAST VISUAL FIELD TEST; Diagnostic Test: SITA STANDARD VISUAL FIELD TEST |
| SITA STANDARD then SITA FAST | Active comparator | SITA FAST and SITA STANDARD Receives: Diagnostic Test: SITA FAST VISUAL FIELD TEST; Diagnostic Test: SITA STANDARD VISUAL FIELD TEST |
What is being measured
The primary outcome is the main question the study is designed to answer.
specificity of the visual field tests
specificity
Measured: 1 year
Secondary outcomes (2)
Patients' rating of test difficulty
number
Measured: 1 year
The number of "questions asked" (number of presented stimuli).
number
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter, University of Plymouth
- Responsible party
- Sponsor
- Investigators
- Michael Smith, MBChB, Principal investigator, Royal Devon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192085
- Sponsor's protocol ID
- MS/22/02/17
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificity and Patient Perception of SITA-Standard Compared to SITA-Fast Visual Fields in Patients Suspected of Having Glaucoma
- ClinicalTrials.gov ID
- NCT03192085
- Acronym / sponsor ID
- MS/22/02/17
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter, University of Plymouth
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
| Arm | Type | Receives |
|---|---|---|
| SITA FAST then SITA STANDARD | Other | Diagnostic Test: SITA FAST VISUAL FIELD TEST, Diagnostic Test: SITA STANDARD VISUAL FIELD TESTSITA FAST and SITA STANDARD |
| SITA STANDARD then SITA FAST | Active comparator | Diagnostic Test: SITA FAST VISUAL FIELD TEST, Diagnostic Test: SITA STANDARD VISUAL FIELD TESTSITA FAST and SITA STANDARD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SITA FAST VISUAL FIELD TESTDiagnostic test for glaucoma | Diagnostic test | SITA FAST then SITA STANDARD, SITA STANDARD then SITA FAST |
| SITA STANDARD VISUAL FIELD TESTDiagnostic test for glaucoma | Diagnostic test | SITA FAST then SITA STANDARD, SITA STANDARD then SITA FAST |
Primary outcome
specificity of the visual field tests
Time frame: 1 year
specificity
2 secondary outcomes
Patients' rating of test difficulty
Time frame: 1 year
The number of "questions asked" (number of presented stimuli).
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Smith, MBChB principal investigator
Royal Devon
Questions about this trial
What is this clinical trial studying?
A study testing SITA FAST VISUAL FIELD TEST and SITA STANDARD VISUAL FIELD TEST in people with Glaucoma, run by Royal Devon and Exeter NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact michael Smith, MBCHB (+44 (0)1392-406316, Michael.smith26@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specificity of the visual field tests (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.