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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

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date June 7, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Diagnostic performance of Optical Coherent Tomography [ Time Frame: 12 months ]
    Sensitivity and specificity for Optical Coherent Tomography in the detection of early glaucoma.
  • Diagnostic performance of Standard Automated perimetry [ Time Frame: 12 months ]
    Sensitivity and specificity for Standard Automated perimetry in the detection of early glaucoma.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)
Official Title  ICMJE Diagnostic Performance of Smart Supra Perimetry (SSP) in Comparison With Standard Automated Perimetry (SAP) and Ocular Coherence Tomography (OCT).
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Glaucoma, Suspect
  • Glaucoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Non-Glaucoma Patient Arm
    All participants will complete the same assessments
    Interventions:
    • Diagnostic Test: Humphrey Visual Field Test
    • Diagnostic Test: Optical Coherence Tomography (OCT) Scan
    • Diagnostic Test: Smart Perimetry - Henson 9000
  • Experimental: Glaucoma Patient Arm
    All participants will complete the same assessments
    Interventions:
    • Diagnostic Test: Humphrey Visual Field Test
    • Diagnostic Test: Optical Coherence Tomography (OCT) Scan
    • Diagnostic Test: Smart Perimetry - Henson 9000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Charlene A Hyde 0161 701 0848 charlene.hyde@mft.nhs.uk
Contact: Monika Cien 0161 701 1765 monika.cien@mft.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03978546
Other Study ID Numbers  ICMJE 250459
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Manchester University NHS Foundation Trust
Study Sponsor  ICMJE Manchester University NHS Foundation Trust
Collaborators  ICMJE
  • University of Manchester
  • Columbia University
Investigators  ICMJE Not Provided
PRS Account Manchester University NHS Foundation Trust
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP