NCT03978546

Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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

• Glaucoma, Suspect
• Glaucoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-11
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2019-06-07
• Last updated: 2022-08-31

Locations

1 site across 1 country: United Kingdom