NCT02594280

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

October 30, 2015

Last Update Submit

January 23, 2018

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (24)

  • VEP Amplitude at 15% Contrast

    Record the VEP Amplitude at 15% contrast stimulus.

    Within 1 month prior to treatment

  • VEP Amplitude at 15% Contrast

    Record the VEP Amplitude at 15% contrast stimulus.

    3 months post treatment

  • VEP Amplitude at 15% Contrast

    Record the VEP Amplitude at 15% contrast stimulus

    6 months post treatment

  • VEP Latency at 15% Contrast

    Record the VEP Latency at 15% contrast stimulus.

    Within 1 month prior to treatment

  • VEP Latency at 15% Contrast

    Record the VEP Latency at 15% contrast stimulus

    3 months post treatment

  • VEP Latency at 15% Contrast

    Record the VEP Latency at 15% contrast stimulus

    6 months post treatment

  • VEP Amplitude at 85% Contrast

    Record the VEP Amplitude at 85% contrast stimulus.

    Within 1 month prior to treatment

  • VEP Amplitude at 85% Contrast

    Record the VEP Amplitude at 85% contrast stimulus.

    3 months post treatment

  • VEP Amplitude at 85% Contrast

    Record the VEP Amplitude at 85% contrast stimulus.

    6 months post treatment

  • VEP Latency at 85% Contrast

    Record the VEP Latency at 85% contrast stimulus

    Within 1 month prior to treatment

  • VEP Latency at 85% Contrast

    Record the VEP Latency at 85% contrast stimulus

    3 months post treatment

  • VEP Latency at 85% Contrast

    Record the VEP Latency at 85% contrast stimulus

    6 months post treatment

  • PERG Magnitude at 16 degree stimulus

    Record the PERG Magnitude at 16 degree stimulus

    Within 1 month prior to treatment

  • PERG Magnitude at 16 degree stimulus

    Record the PERG Magnitude at 16 degree stimulus

    3 months post treatment

  • PERG Magnitude at 16 degree stimulus

    Record the PERG Magnitude at 16 degree stimulus

    6 months post treatment

  • PERG MagnitudeD at 16 degree stimulus

    Record the PERG MagnitudeD at 16 degree stimulus

    Within 1 month prior to treatment

  • PERG MagnitudeD at 16 degree stimulus

    Record the PERG MagnitudeD at 16 degree stimulus

    3 months post treatment

  • PERG MagnitudeD at 16 degree stimulus

    Record the PERG MagnitudeD at 16 degree stimulus

    6 months post treatment

  • PERG Magnitude at 24 degree stimulus

    Record the PERG Magnitude at 24 degree stimulus

    Within 1 month prior to treatment

  • PERG Magnitude at 24 degree stimulus

    Record the PERG Magnitude at 24 degree stimulus

    3 months post treatment

  • PERG Magnitude at 24 degree stimulus

    Record the PERG Magnitude at 24 degree stimulus

    6 months post treatment

  • PERG MagnitudeD at 24 degree stimulus

    Record the PERG MagnitudeD at 24 degree stimulus

    Within 1 month prior to treatment

  • PERG MagnitudeD at 24 degree stimulus

    Record the PERG MagnitudeD at 24 degree stimulus

    3 months post treatment

  • PERG MagnitudeD at 24 degree stimulus

    Record the PERG MagnitudeD at 24 degree stimulus

    6 months post treatment

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Bach M, Brigell MG, Hawlina M, Holder GE, Johnson MA, McCulloch DL, Meigen T, Viswanathan S. ISCEV standard for clinical pattern electroretinography (PERG): 2012 update. Doc Ophthalmol. 2013 Feb;126(1):1-7. doi: 10.1007/s10633-012-9353-y. Epub 2012 Oct 17.

    PMID: 23073702BACKGROUND

  • Banitt MR, Ventura LM, Feuer WJ, Savatovsky E, Luna G, Shif O, Bosse B, Porciatti V. Progressive loss of retinal ganglion cell function precedes structural loss by several years in glaucoma suspects. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):2346-52. doi: 10.1167/iovs.12-11026.

    PMID: 23412088BACKGROUND

  • Bode SF, Jehle T, Bach M. Pattern electroretinogram in glaucoma suspects: new findings from a longitudinal study. Invest Ophthalmol Vis Sci. 2011 Jun 16;52(7):4300-6. doi: 10.1167/iovs.10-6381.

    PMID: 21372021BACKGROUND

  • Parisi V, Miglior S, Manni G, Centofanti M, Bucci MG. Clinical ability of pattern electroretinograms and visual evoked potentials in detecting visual dysfunction in ocular hypertension and glaucoma. Ophthalmology. 2006 Feb;113(2):216-28. doi: 10.1016/j.ophtha.2005.10.044. Epub 2006 Jan 10.

    PMID: 16406535BACKGROUND

  • Dodt E. The electrical response of the human eye to patterned stimuli: clinical observations. Doc Ophthalmol. 1987 Mar;65(3):271-86. doi: 10.1007/BF00149934.

    PMID: 3678000BACKGROUND

  • Carr MD RE. The Pattern Electroretinogram (PERG). Paper presented at: NANOS, 1988.

    BACKGROUND

  • Ventura LM, Porciatti V. Pattern electroretinogram in glaucoma. Curr Opin Ophthalmol. 2006 Apr;17(2):196-202. doi: 10.1097/01.icu.0000193082.44938.3c.

    PMID: 16552256BACKGROUND

  • Bach M, Unsoeld AS, Philippin H, Staubach F, Maier P, Walter HS, Bomer TG, Funk J. Pattern ERG as an early glaucoma indicator in ocular hypertension: a long-term, prospective study. Invest Ophthalmol Vis Sci. 2006 Nov;47(11):4881-7. doi: 10.1167/iovs.05-0875.

    PMID: 17065502BACKGROUND

  • Kono Y, Jonas JB, Zangwill L, Berry CC, Weinreb RN. Agreement of measurement of parapapillary atrophy with confocal scanning laser ophthalmoscopy and planimetry of photographs. J Glaucoma. 1999 Apr;8(2):105-10.

    PMID: 10209726BACKGROUND

  • Holder GE. Pattern electroretinography (PERG) and an integrated approach to visual pathway diagnosis. Prog Retin Eye Res. 2001 Jul;20(4):531-61. doi: 10.1016/s1350-9462(00)00030-6.

    PMID: 11390258BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Wollstein Gadi, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristy Truman

CONTACT

412-383-8778trumank@upmc.edu

Melessa Salay, BS

CONTACT

412-383-9884salaym@upmc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 3, 2015

Study Start

February 15, 2018

Primary Completion

December 15, 2018

Study Completion

May 1, 2019

Last Updated

January 25, 2018

Record last verified: 2018-01