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Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

NCT03978546 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-31

No results posted yet for this study

Summary

Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients.

Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP 24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. The sensitivity and specificity of the SAP and SSP tests will be established along with test duration. The size and location of defects established with both the SAP and SSP strategies will also be compared.

Conditions

Interventions

DIAGNOSTIC_TEST

Humphrey Visual Field Test

SITA Standard and 24-2 and 10-2 visual field tests

DIAGNOSTIC_TEST

Optical Coherence Tomography (OCT) Scan

Circle and Wide Angle Scans

DIAGNOSTIC_TEST

Smart Perimetry - Henson 9000

24+10-2 Smart Supra test

Sponsors & Collaborators

  • University of Manchester

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978546 on ClinicalTrials.gov