NCT03192085

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

June 12, 2017

Last Update Submit

June 15, 2017

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • specificity of the visual field tests

    specificity

    1 year

Secondary Outcomes (2)

  • Patients' rating of test difficulty

    1 year

  • The number of "questions asked" (number of presented stimuli).

    1 year

Study Arms (2)

SITA FAST then SITA STANDARD

OTHER

SITA FAST and SITA STANDARD

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

SITA STANDARD then SITA FAST

ACTIVE COMPARATOR

SITA FAST and SITA STANDARD

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

Interventions

SITA FAST VISUAL FIELD TESTDIAGNOSTIC_TEST

Diagnostic test for glaucoma

SITA FAST then SITA STANDARDSITA STANDARD then SITA FAST
SITA STANDARD VISUAL FIELD TESTDIAGNOSTIC_TEST

Diagnostic test for glaucoma

SITA FAST then SITA STANDARDSITA STANDARD then SITA FAST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old attending the West of England Eye Unit Glaucoma Service who have been newly referred for suspected glaucoma.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Michael Smith, MBChB

    Royal Devon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

michael Smith, MBCHB

CONTACT

+44 (0)1392-406316Michael.smith26@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 19, 2017

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 19, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share