Comparison of SITA-Standard Compared to SITA-Fast Visual... | NCT03192085

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

NCT03192085

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Status

Unknown status

Last Update Posted

Jun 19, 2017Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Glaucoma

Interventions

SITA FAST VISUAL FIELD TEST
SITA STANDARD VISUAL FIELD TEST

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2017Estimated

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jun 12, 2017

First Submission Date that Met QC Criteria

Jun 15, 2017

First Posted Date

Jun 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2017

Last Update Posted Date

Jun 19, 2017Actual

Name	Class
University of Exeter	OTHER
University of Plymouth	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SITA FAST then SITA STANDARD	Other	SITA FAST and SITA STANDARD	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	Diagnostic Test: SITA FAST VISUAL FIELD TEST Diagnostic Test: SITA STANDARD VISUAL FIELD TEST

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SITA FAST VISUAL FIELD TEST	Diagnostic Test	Diagnostic test for glaucoma	SITA FAST then SITA STANDARD SITA STANDARD then SITA FAST

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
specificity of the visual field tests	specificity	1 year

Secondary Outcomes

Measure	Description	Time Frame
Patients' rating of test difficulty	number	1 year
The number of "questions asked" (number of presented stimuli).	number	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
michael Smith, MBCHB	Contact	+44 (0)1392-406316		Michael.smith26@nhs.net

Overall Officials

Name	Affiliation	Role
Michael Smith, MBChB	Royal Devon	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided