Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

Glaucoma Clinical Trial

— DPSSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978546
• Other study ID #: 250459
• Status: Completed
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Suspect
• Ocular Hypertension

Intervention

Diagnostic Test:
• Humphrey Visual Field Test
SITA Standard and 24-2 and 10-2 visual field tests
• Optical Coherence Tomography (OCT) Scan
Circle and Wide Angle Scans
• Smart Perimetry - Henson 9000
24+10-2 Smart Supra test

Locations

Country	Name	City	State
United Kingdom	Manchester Royal Eye Hospital	Manchester

Sponsors (3)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Columbia University, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic performance of Optical Coherent Tomography	Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.	12 months
Secondary	Diagnostic performance of Standard Automated perimetry	Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.	12 months