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

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ClinicalTrials.gov Identifier: NCT03978546
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
University of Manchester
Columbia University
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Glaucoma, Suspect Glaucoma Diagnostic Test: Humphrey Visual Field Test Diagnostic Test: Optical Coherence Tomography (OCT) Scan Diagnostic Test: Smart Perimetry - Henson 9000 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Non-Glaucoma Patient Arm
All participants will complete the same assessments
Diagnostic Test: Humphrey Visual Field Test
SITA Standard and 24-2 and 10-2 visual field tests

Diagnostic Test: Optical Coherence Tomography (OCT) Scan
Circle and Wide Angle Scans

Diagnostic Test: Smart Perimetry - Henson 9000
24+10-2 Smart Supra test

Experimental: Glaucoma Patient Arm
All participants will complete the same assessments
Diagnostic Test: Humphrey Visual Field Test
SITA Standard and 24-2 and 10-2 visual field tests

Diagnostic Test: Optical Coherence Tomography (OCT) Scan
Circle and Wide Angle Scans

Diagnostic Test: Smart Perimetry - Henson 9000
24+10-2 Smart Supra test




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978546


Contacts
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Contact: Charlene A Hyde 0161 701 0848 charlene.hyde@mft.nhs.uk
Contact: Monika Cien 0161 701 1765 monika.cien@mft.nhs.uk

Locations
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United Kingdom
Manchester Royal Eye Hospital Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Charlene A Hyde    0161 701 0848    charlene.hyde@mft.nhs.uk   
Principal Investigator: Subash Sukumar         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
University of Manchester
Columbia University

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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03978546     History of Changes
Other Study ID Numbers: 250459
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manchester University NHS Foundation Trust:
glaucoma

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases