To Study the Function of the Retina in Glaucoma Patients Using PERG

A Prospective, Longitudinal Study to Evaluate the Function of the Retina and Visual Pathways in Glaucoma Patients Using PERG

The purpose of this trial is to evaluate the performance of a new diagnostic device in the diagnosis and management of glaucoma. We will use this new device (PERG) to evaluate the function of the retina in glaucoma patients. This device is safe for the patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glaucoma

Detailed Description

Glaucoma is one of the leading causes of blindness worldwide. It's an optic neuropathy characterized by the progressive death of retinal ganglion cells.

In laboratories, it's possible to measure the electrical activity of retinal ganglion cells (RGC). Some researchers found that RGC showed electrical anomalies before dying. This decrease of electrical activity can be measured by using pattern electroretinography (PERG). Unfortunately, these measures could not be obtained in clinics before this new device.

For this reason, Diopsys developed a new device that can measure PERG directly in clinics, allowing physicians to have these data earlier to help them diagnose pathologies such as glaucoma or other ganglion cells abnormalities.

Currently, it is known that glaucoma is difficult to diagnose in the early stages and it's challenging to decide when to start a treatment.

In this study, our purpose is to use this new device to evaluate its efficacy in the diagnosis and management of glaucoma.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Switzerland
  • Canton De Vaud
    • Lausanne, Canton De Vaud, Switzerland, 1006
      • Montchoisi Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center

Description

Inclusion Criteria:

• Glaucoma (all types of glaucoma);
• Ocular hypertensive (Suspicion of glaucoma);
• Control Patients (without any suspicion/sign of glaucoma);
• Have given written informed consent, prior to any investigational procedures;
• Aged 18 years of either sex.

Exclusion Criteria:

• Patients not able to understand the character of the study
• Participation in other clinical research within the last 4 weeks
• Other diseases that may cause visual field loss or optic disc abnormalities
• Systemic diseases that may affect PERG amplitude such as diabetes, parkinsonism, multiple sclerosis
• Poor best corrected visual acuity outside the limits recommended for the test
• Patients with high myopia (>5D)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Variability of the device; We will study the repeatability and reliability of the Diopsys® ERG Vision Testing Systems in normal non-glaucomatous people and in those with suspicion of glaucoma or confirmed glaucoma.
Diagnosis and progression of glaucoma; Patients who have a suspicion of glaucoma and patients with confirmed glaucoma will be included. PERG data obtained by the Diopsys® ERG Vision Testing Systems will be analyzed to study the PERG changes in different clinical situations, such as early glaucoma and progression of glaucoma.
Effect of medical/surgical intervention; Patients will undergo standard treatment based on their medical history and we will observe the PERG changes induced by these treatments (eye drops, laser or surgery) with the Diopsys® ERG Vision Testing Systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnitude, μV	Strength of the signal	4 years
Magnitude D, μV	Strength and phase	4 years
MagD/Mag Ratio (no units)	Ratio between MagD and Mag	4 years
SNR, dB	Signal to Noise Ratio	4 years

Collaborators and Investigators

• Sponsor: Swiss Vision Network
• Investigators: Principal Investigator: Kaweh Mansouri, MD, Glaucoma center, Montchoisi clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: PERG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO