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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03330574|
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease|
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|
|Estimated Enrollment :||200 participants|
|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|
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.
- Magnitude, μV [ Time Frame: 4 years ]Strength of the signal
- Magnitude D, μV [ Time Frame: 4 years ]Strength and phase
- MagD/Mag Ratio (no units) [ Time Frame: 4 years ]Ratio between MagD and Mag
- SNR, dB [ Time Frame: 4 years ]Signal to Noise Ratio
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
|Contact: Kaweh Mansouri, MDfirstname.lastname@example.org|
|Lausanne, Canton de Vaud, Switzerland, 1006|
|Contact: Kaweh Mansouri, MD, MPH email@example.com|
|Contact: Adel Ouabas, MD firstname.lastname@example.org|
|Principal Investigator: Kaweh Mansouri, MD, MPH|
|Sub-Investigator: André Mermoud, MD|
|Principal Investigator:||Kaweh Mansouri, MD||Glaucoma Center, Montchoisi Clinic|