Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

NHS Foundation Trust

Status: Completed

Conditions: Glaucoma; Glaucoma, Suspect

Treatments: Diagnostic Test: Smart Perimetry - Henson 9000; Diagnostic Test: Humphrey Visual Field Test; Diagnostic Test: Optical Coherence Tomography (OCT) Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT03978546

250459

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Non-Glaucoma Patient Arm

Experimental group

Description:

All participants will complete the same assessments

Treatment:

Diagnostic Test: Optical Coherence Tomography (OCT) Scan

Diagnostic Test: Smart Perimetry - Henson 9000

Diagnostic Test: Humphrey Visual Field Test

Glaucoma Patient Arm

Experimental group

Description:

All participants will complete the same assessments

Treatment:

Diagnostic Test: Optical Coherence Tomography (OCT) Scan

Diagnostic Test: Smart Perimetry - Henson 9000

Diagnostic Test: Humphrey Visual Field Test