Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

NCT03978546 | Completed

• 1 other identifier: 250459
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Suspect; Glaucoma

Keywords

glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic performance of Optical Coherent Tomography

  12 months

• Diagnostic performance of Standard Automated perimetry

  12 months

Study Arms (2)

Non-Glaucoma Patient Arm

EXPERIMENTAL

All participants will complete the same assessments

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

Glaucoma Patient Arm

EXPERIMENTAL

All participants will complete the same assessments

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

Interventions

Humphrey Visual Field Test DIAGNOSTIC_TEST

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

Glaucoma Patient Arm; Non-Glaucoma Patient Arm

Optical Coherence Tomography (OCT) Scan DIAGNOSTIC_TEST

Circle and Wide Angle Scans

Glaucoma Patient Arm; Non-Glaucoma Patient Arm

Smart Perimetry - Henson 9000 DIAGNOSTIC_TEST

24+10-2 Smart Supra test

Glaucoma Patient Arm; Non-Glaucoma Patient Arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anomalous discs, Tilted discs, myopic discs.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator
• Columbia University: collaborator

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Sukumar S, Harper RA, Tsamis E, Hood D, Henson DB. Diagnostic Accuracy of Smart Supra Perimetry in Comparison With Standard Automated Perimetry in the Detection of Early Glaucoma. J Glaucoma. 2025 Sep 1;34(9):710-718. doi: 10.1097/IJG.0000000000002596. Epub 2025 May 14.

  PMID: 40366217 DERIVED

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma

Interventions

Tomography, Optical Coherence; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: All participants will have the same examinations but in a randomised order, these examinations are: Humphrey Visual Fields Test (10-2 and 24-2, SITA Standard), OCT Scan (Cube scan, Wide angle and macula scan) and Smart Perimetry - Henson 9000.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 7, 2019
• Study Start: June 11, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)