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Benchmarking Management of Glaucoma Using the Diopsys VEP/PERG Protocols.

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ClinicalTrials.gov Identifier: NCT02594280
Recruitment Status : Unknown
Verified January 2018 by Diopsys, Inc..
Recruitment status was:  Not yet recruiting
First Posted : November 3, 2015
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Diopsys, Inc.

Brief Summary:
Establish electrophysiological benchmarks, using the Diopsys Visual Evoked Potential/ Pattern ERG (VEP/PERG) protocols of populations with Glaucoma following: 1) Baseline VEP/ERG prior to treatment; and 2) VEP/PERG after treatment.

Condition or disease
Glaucoma

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational/Prospective Study for Benchmarking the Management of Glaucoma With Selective Laser Trabeculoplasty (SLT) or Trabecular Stent Bypass Microsurgery, Using the Diopsys Visual Evoked Potential/Pattern ERG Protocols
Estimated Study Start Date : February 15, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
Selective Laser Trabeculoplasty (SLT)SLT
Monitor glaucoma patients that are scheduled to be treated with Selective Laser Trabeculoplasty (SLT) with VEP/PERG. The treatment is not dependent on the study.
Trabecular stent bypass microsurgery
Monitor glaucoma patients that are scheduled to be treated with trabecular stent bypass microsurgery with VEP/PERG.The treatment is not dependent on the study.



Primary Outcome Measures :
  1. VEP Amplitude at 15% Contrast [ Time Frame: Within 1 month prior to treatment ]
    Record the VEP Amplitude at 15% contrast stimulus.

  2. VEP Amplitude at 15% Contrast [ Time Frame: 3 months post treatment ]
    Record the VEP Amplitude at 15% contrast stimulus.

  3. VEP Amplitude at 15% Contrast [ Time Frame: 6 months post treatment ]
    Record the VEP Amplitude at 15% contrast stimulus

  4. VEP Latency at 15% Contrast [ Time Frame: Within 1 month prior to treatment ]
    Record the VEP Latency at 15% contrast stimulus.

  5. VEP Latency at 15% Contrast [ Time Frame: 3 months post treatment ]
    Record the VEP Latency at 15% contrast stimulus

  6. VEP Latency at 15% Contrast [ Time Frame: 6 months post treatment ]
    Record the VEP Latency at 15% contrast stimulus

  7. VEP Amplitude at 85% Contrast [ Time Frame: Within 1 month prior to treatment ]
    Record the VEP Amplitude at 85% contrast stimulus.

  8. VEP Amplitude at 85% Contrast [ Time Frame: 3 months post treatment ]
    Record the VEP Amplitude at 85% contrast stimulus.

  9. VEP Amplitude at 85% Contrast [ Time Frame: 6 months post treatment ]
    Record the VEP Amplitude at 85% contrast stimulus.

  10. VEP Latency at 85% Contrast [ Time Frame: Within 1 month prior to treatment ]
    Record the VEP Latency at 85% contrast stimulus

  11. VEP Latency at 85% Contrast [ Time Frame: 3 months post treatment ]
    Record the VEP Latency at 85% contrast stimulus

  12. VEP Latency at 85% Contrast [ Time Frame: 6 months post treatment ]
    Record the VEP Latency at 85% contrast stimulus

  13. PERG Magnitude at 16 degree stimulus [ Time Frame: Within 1 month prior to treatment ]
    Record the PERG Magnitude at 16 degree stimulus

  14. PERG Magnitude at 16 degree stimulus [ Time Frame: 3 months post treatment ]
    Record the PERG Magnitude at 16 degree stimulus

  15. PERG Magnitude at 16 degree stimulus [ Time Frame: 6 months post treatment ]
    Record the PERG Magnitude at 16 degree stimulus

  16. PERG MagnitudeD at 16 degree stimulus [ Time Frame: Within 1 month prior to treatment ]
    Record the PERG MagnitudeD at 16 degree stimulus

  17. PERG MagnitudeD at 16 degree stimulus [ Time Frame: 3 months post treatment ]
    Record the PERG MagnitudeD at 16 degree stimulus

  18. PERG MagnitudeD at 16 degree stimulus [ Time Frame: 6 months post treatment ]
    Record the PERG MagnitudeD at 16 degree stimulus

  19. PERG Magnitude at 24 degree stimulus [ Time Frame: Within 1 month prior to treatment ]
    Record the PERG Magnitude at 24 degree stimulus

  20. PERG Magnitude at 24 degree stimulus [ Time Frame: 3 months post treatment ]
    Record the PERG Magnitude at 24 degree stimulus

  21. PERG Magnitude at 24 degree stimulus [ Time Frame: 6 months post treatment ]
    Record the PERG Magnitude at 24 degree stimulus

  22. PERG MagnitudeD at 24 degree stimulus [ Time Frame: Within 1 month prior to treatment ]
    Record the PERG MagnitudeD at 24 degree stimulus

  23. PERG MagnitudeD at 24 degree stimulus [ Time Frame: 3 months post treatment ]
    Record the PERG MagnitudeD at 24 degree stimulus

  24. PERG MagnitudeD at 24 degree stimulus [ Time Frame: 6 months post treatment ]
    Record the PERG MagnitudeD at 24 degree stimulus



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population is a group of glaucoma patients that are scheduled for 1) Selective Laser Trabeculoplasty or 2) Trabecular stent bypass microsurgery as a treatment.
Criteria

Inclusion Criteria:

  • Patient will have repeatable abnormal SAP results (pattern standard deviation with p ≤5% and/or Glaucoma Hemifield Test outside normal limits)
  • Glaucomatous optic disc appearance (those with cup to disc area ratio, rim thinning or RNFL defects indicative of glaucoma)
  • Repeatable intraocular pressure ≥23 mmHg, in at least one eye.
  • The last SAP test of all participants will be classified following the Glaucoma Staying System (GSS).

Exclusion Criteria:

  • A spherical refraction outside + 5.0 D and cylinder correction outside + 3.0 D.
  • Intraocular surgery in the study eye (except non-complicated cataract or refractive surgery performed less than 1 year before enrollment).
  • Any prior vitrectomy
  • Any prior macular or pan retinal photocoagulation laser
  • History of neurologic condition known to affect visual function.
  • Inability to obtain a reliable PERG/VEP test.

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): NCT02594280


Contacts
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Contact: Kristy Truman 412-383-8778 trumank@upmc.edu
Contact: Melessa Salay, BS 412-383-9884 salaym@upmc.edu

Sponsors and Collaborators
Diopsys, Inc.
University of Pittsburgh
Investigators
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Principal Investigator: Wollstein Gadi, MD University of Pittsburgh
Additional Information:
Publications:
Carr MD RE. The Pattern Electroretinogram (PERG). Paper presented at: NANOS, 1988.

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Responsible Party: Diopsys, Inc.
ClinicalTrials.gov Identifier: NCT02594280    
Obsolete Identifiers: NCT02555436
Other Study ID Numbers: 2015-UPMC-01
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases