search
Back to results

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

Primary Purpose

Glaucoma, Suspect, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Humphrey Visual Field Test
Optical Coherence Tomography (OCT) Scan
Smart Perimetry - Henson 9000
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma, Suspect focused on measuring glaucoma

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Manchester Royal Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-Glaucoma Patient Arm

Glaucoma Patient Arm

Arm Description

All participants will complete the same assessments

All participants will complete the same assessments

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diagnostic performance of Optical Coherent Tomography
Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.
Diagnostic performance of Standard Automated perimetry
Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.

Full Information

First Posted
May 16, 2019
Last Updated
August 30, 2022
Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester, Columbia University
search

1. Study Identification

Unique Protocol Identification Number
NCT03978546
Brief Title
Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)
Acronym
DPSSP
Official Title
Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
University of Manchester, Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Suspect, Glaucoma
Keywords
glaucoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Glaucoma Patient Arm
Arm Type
Experimental
Arm Description
All participants will complete the same assessments
Arm Title
Glaucoma Patient Arm
Arm Type
Experimental
Arm Description
All participants will complete the same assessments
Intervention Type
Diagnostic Test
Intervention Name(s)
Humphrey Visual Field Test
Intervention Description
SITA Standard and 24-2 and 10-2 visual field tests
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical Coherence Tomography (OCT) Scan
Intervention Description
Circle and Wide Angle Scans
Intervention Type
Diagnostic Test
Intervention Name(s)
Smart Perimetry - Henson 9000
Intervention Description
24+10-2 Smart Supra test
Primary Outcome Measure Information:
Title
Diagnostic performance of smart supra perimetry
Description
Area under the curve for Smart Suprathrold Perimetry using probability thresholds to differentiate early glaucoma from non-glaucomatous visual fields.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diagnostic performance of Optical Coherent Tomography
Description
Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.
Time Frame
12 months
Title
Diagnostic performance of Standard Automated perimetry
Description
Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Manchester Royal Eye Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

We'll reach out to this number within 24 hrs