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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330574
Recruitment Status : Unknown
Verified October 2017 by dr. Kaweh Mansouri, Swiss Vision Network.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
dr. Kaweh Mansouri, Swiss Vision Network

Study Description
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Brief 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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Longitudinal Study to Evaluate the Function of the Retina and Visual Pathways in Glaucoma Patients Using PERG
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Magnitude, μV [ Time Frame: 4 years ]
    Strength of the signal

  2. Magnitude D, μV [ Time Frame: 4 years ]
    Strength and phase

  3. MagD/Mag Ratio (no units) [ Time Frame: 4 years ]
    Ratio between MagD and Mag

  4. SNR, dB [ Time Frame: 4 years ]
    Signal to Noise Ratio


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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)
Contacts and Locations
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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): NCT03330574


Contacts
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Contact: Kaweh Mansouri, MD 0041791767267 kmansouri@gsvn.ch

Locations
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Switzerland
Montchoisi Clinic Recruiting
Lausanne, Canton de Vaud, Switzerland, 1006
Contact: Kaweh Mansouri, MD, MPH       kmansouri@gsvn.ch   
Contact: Adel Ouabas, MD       adel1987@gmail.com   
Principal Investigator: Kaweh Mansouri, MD, MPH         
Sub-Investigator: André Mermoud, MD         
Sponsors and Collaborators
Swiss Vision Network
Investigators
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Principal Investigator: Kaweh Mansouri, MD Glaucoma Center, Montchoisi Clinic
More Information
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Responsible Party: dr. Kaweh Mansouri, Doctor, Swiss Vision Network
ClinicalTrials.gov Identifier: NCT03330574    
Other Study ID Numbers: PERG-01
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by dr. Kaweh Mansouri, Swiss Vision Network:
Glaucoma
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases