CLAD Deconvolved PERG Responses in Glaucoma Patients

May 13, 2024 updated by: Jorvec Corp.
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The PERG is recorded from small metallic cups taped on the skin or contact electrodes on the face similarly to an electrocardiogram except that the location is the skin around the eyes.

The only physical contact the subject will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test the subject will be asked to look at a visual stimulus display for about 3 minutes. Depending on the experimental protocol, the subject may be asked to either sit during the test or to lie down in a bed. Lying down will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases.

For OCT evaluation, the pupil will be dilated with drops similar to those used in a standard eye exam. The subject will have to briefly look at a mark inside the instrument one eye at a time.

For Visual field (VF) evaluation, the subject will be asked to look at a fixation mark inside the Visual Field testing equipment and asked to signal when they see small lights in their periphery.

PERG, OCT and VF will be performed during the same day of the visit. If the participant has already done these tests in the past, as part of another study or as part of standard treatment, the results of these tests will be obtained from shier record, and be included in this study.

RISKS:

For the PERG, the only significant risk to you is a small chance of skin discomfort from the cleansing agent for skin electrodes, which should go away without treatment. For OCT, there is a rare risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even lower if you did not have any reaction during your previous eye exams. In case of an allergic reaction, your eye doctor will immediately treat it. If you had previous problems with pupil dilation, you may wish to speak to your eye doctor about the option of doing this additional test. There are no significant risks associated with VF testing

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Study Population

Adults between the ages of 18 and 85 years, with and without suspected glaucoma.

Description

Inclusion Criteria:

  1. Age 18 to 85 years, inclusive
  2. Refractive errors within -5 to +3 diopters
  3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
  4. Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on all global indices in two consecutive sessions 6 months apart)
  5. Minimum untreated Intraocular pressure IOP of 15 mm Hg

  6. Glaucoma Suspect Status defined as one or more of the following:

    • Glaucomatous optic disc appearance (vertical cup-to-disc ratio [C/D] ≥0.5
    • Cup disc ratio asymmetry ≥0.2
    • Localized thinning of the disc
    • Presence or history of splinter disc hemorrhage
    • Moderately increased IOP (>21 to <28 mm Hg).
    • Family history of vision loss for glaucoma

Exclusion Criteria:

  1. Age-related macular degeneration
  2. Diabetes
  3. Parkinson's disease
  4. Multiple sclerosis
  5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  6. Pregnant or nursing women.
  7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
  8. An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
  9. An OCT abnormal enough in a pattern consistent with glaucoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glaucoma Suspects
Patients with suspicion of glaucoma based on positive factors of disease.
Diagnostic test: Pattern Electroretinogram
Non-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye.
Active Comparator: Controls
Age matched controls to the glaucoma suspect group with no indications of glaucoma.
Diagnostic test: Pattern Electroretinogram
Non-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PERG Amplitude
Time Frame: Immediately after measurement
Response amplitude measured in microvolts
Immediately after measurement
PERG Latency
Time Frame: Immediately after measurement
Response feature latency in milliseconds following the stimulus delivery
Immediately after measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jorvec Corp.

Collaborators

University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Estimated)

May 15, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERGCLAD001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals. In addition, a de-identified database containing subject gender, age at recording, raw localization and tracking data, will be maintained. The data will be shared with other centers conducting similar research under appropriate IRB approval.

IPD Sharing Time Frame

Data will be available six months after the completion of the project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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