Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study) (DPSSP)

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Glaucoma, Suspect
• Intervention / Treatment: Diagnostic test: Humphrey Visual Field Test; Diagnostic test: Optical Coherence Tomography (OCT) Scan; Diagnostic test: Smart Perimetry - Henson 9000

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester Royal Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-Glaucoma Patient Arm; All participants will complete the same assessments	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
Experimental: Glaucoma Patient Arm; All participants will complete the same assessments	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of Optical Coherent Tomography	Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.	12 months
Diagnostic performance of Standard Automated perimetry	Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.	12 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Columbia University; University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular Hypertension
• Other Study ID Numbers: 250459

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