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: SITA FAST VISUAL FIELD TEST
Diagnostic test for glaucoma
Diagnostic test: SITA STANDARD VISUAL FIELD TEST
Diagnostic test for glaucoma
Active Comparator: SITA STANDARD then SITA FAST
SITA FAST and SITA STANDARD
Diagnostic test: SITA FAST VISUAL FIELD TEST
Diagnostic test for glaucoma
Diagnostic test: SITA STANDARD VISUAL FIELD TEST
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.

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Collaborators

University of Plymouth
University of Exeter

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.

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