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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Manchester, United Kingdom, M13 9WL
- Manchester Royal Eye Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Non-Glaucoma Patient Arm
All participants will complete the same assessments
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SITA Standard and 24-2 and 10-2 visual field tests
Circle and Wide Angle Scans
24+10-2 Smart Supra test
|
|
Experimental: Glaucoma Patient Arm
All participants will complete the same assessments
|
SITA Standard and 24-2 and 10-2 visual field tests
Circle and Wide Angle Scans
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
Time Frame: 12 months
|
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
Time Frame: 12 months
|
Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.
|
12 months
|
|
Diagnostic performance of Standard Automated perimetry
Time Frame: 12 months
|
Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 250459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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