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

NCT ID: NCT03192085

Last Updated: 2017-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised crossover trial of diagnostic test with assessment of comparative accuracy - feasibility study.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SITA FAST then SITA STANDARD

SITA FAST and SITA STANDARD

Group Type OTHER

SITA FAST VISUAL FIELD TEST

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for glaucoma

SITA STANDARD VISUAL FIELD TEST

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for glaucoma

SITA STANDARD then SITA FAST

SITA FAST and SITA STANDARD

Group Type ACTIVE_COMPARATOR

SITA FAST VISUAL FIELD TEST

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for glaucoma

SITA STANDARD VISUAL FIELD TEST

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for glaucoma

Interventions

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SITA FAST VISUAL FIELD TEST

Diagnostic test for glaucoma

Intervention Type DIAGNOSTIC_TEST

SITA STANDARD VISUAL FIELD TEST

Diagnostic test for glaucoma

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Exeter

OTHER

Sponsor Role collaborator

University of Plymouth

OTHER

Sponsor Role collaborator

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Smith, MBChB

Role: PRINCIPAL_INVESTIGATOR

Royal Devon

Central Contacts

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michael Smith, MBCHB

Role: CONTACT

+44 (0)1392-406316

Other Identifiers

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MS/22/02/17

Identifier Type: -

Identifier Source: org_study_id

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