Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

Not Applicable

Completed

• Conditions: Glaucoma; Glaucoma, Suspect
• Interventions: Diagnostic Test: Humphrey Visual Field Test; Diagnostic Test: Optical Coherence Tomography (OCT) Scan; Diagnostic Test: Smart Perimetry - Henson 9000

• Registration Number: NCT03978546
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-06-11
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Reliable SAP visual field results (fixation loss < 33%, false positive < 15% and false negative < 20%).
• Visual acuity better or equal to 0.20 logMAR.
• Spherical refractive error within -6.00 to +6.00D and cylindrical error <2.00D
• No ocular co-morbidity likely to affect the visual field or OCT results.
• Age: 40-80 yrs

Additional inclusion criteria for glaucomatous group:

• Optic disc showing glaucomatous changes.
• SAP MD not worse than -6dB

Additional inclusion criteria non-glaucoma group:

• Normal SAP visual field data (MD, PSD, GHT within normal range)
• No evidence of glaucoma or other Ocular co-morbidity in the eye suitable for the study.

Exclusion Criteria

Exclusion criteria glaucomatous and control groups:

• Anomalous discs, Tilted discs, myopic discs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Non-Glaucoma Patient Arm	Humphrey Visual Field Test	All participants will complete the same assessments
Glaucoma Patient Arm	Humphrey Visual Field Test	All participants will complete the same assessments
Glaucoma Patient Arm	Optical Coherence Tomography (OCT) Scan	All participants will complete the same assessments
Non-Glaucoma Patient Arm	Smart Perimetry - Henson 9000	All participants will complete the same assessments
Non-Glaucoma Patient Arm	Optical Coherence Tomography (OCT) Scan	All participants will complete the same assessments
Glaucoma Patient Arm	Smart Perimetry - Henson 9000	All participants will complete the same assessments

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of smart supra perimetry	12 months	Area under the curve for Smart Suprathrold Perimetry using probability thresholds to differentiate early glaucoma from non-glaucomatous visual fields.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of Optical Coherent Tomography	12 months	Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.
Diagnostic performance of Standard Automated perimetry	12 months	Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.

Trial Locations

Locations (1)

Manchester Royal Eye Hospital; 🇬🇧 Manchester, United Kingdom