ClinicalTrials.gg
Status unknownNCT03330574Updated May 5, 2022

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

An observational study in Glaucoma, sponsored by Swiss Vision Network. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Swiss Vision Network · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Glaucoma

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Keywords

  • Glaucoma
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's planned enrollment of 200 is above the median of 101 across 385 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Swiss Vision Network is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Magnitude, μV

    Strength of the signal

    Time frame: 4 years

  2. Magnitude D, μV

    Strength and phase

    Time frame: 4 years

  3. MagD/Mag Ratio (no units)

    Ratio between MagD and Mag

    Time frame: 4 years

  4. SNR, dB

    Signal to Noise Ratio

    Time frame: 4 years

07

Study locations

1 site
  • Montchoisi Clinic
    Lausanne, Canton De Vaud 1006, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03330574
Lead sponsor
Swiss Vision Network
Responsible party
Dr. Kaweh Mansouri (Doctor, Swiss Vision Network) — Principal investigator
First posted
Nov 6, 2017
Start date
Jan 1, 2017
Primary completion
Dec 1, 2020
Completion
Dec 2023 (estimated)
Last update
May 5, 2022

Study contacts

Kaweh Mansouri, MD
principal investigator · Glaucoma Center, Montchoisi Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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