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Completed

NCT Number: NCT03978546

Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

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.

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Key information

Conditions

Glaucoma, Suspect Eye Diseases Glaucoma Ocular Hypertension

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Humphrey Visual Field Test

Diagnostic Test

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

Optical Coherence Tomography (OCT) Scan

Diagnostic Test

Circle and Wide Angle Scans

Smart Perimetry - Henson 9000

Diagnostic Test

24+10-2 Smart Supra test

Primary outcomes

  1. Diagnostic performance of smart supra perimetry

    Time frame: 12 months

    Area under the curve for Smart Suprathrold Perimetry using probability thresholds to differentiate early glaucoma from non-glaucomatous visual fields.

Secondary outcomes

  1. Diagnostic performance of Optical Coherent Tomography

    Time frame: 12 months

    Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.

  2. Diagnostic performance of Standard Automated perimetry

    Time frame: 12 months

    Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Collaborators

  • Columbia University
  • University of Manchester

Registry information

Official study title

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

Acronym: DPSSP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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