GlaucomaNCT03330574
To Study the Function of the Retina in Glaucoma Patients Using PERG
An observational study of Glaucoma, run by Swiss Vision Network at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2017to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Magnitude, μV
Strength of the signal
Measured: 4 years
Magnitude D, μV
Strength and phase
Measured: 4 years
MagD/Mag Ratio (no units)
Ratio between MagD and Mag
Measured: 4 years
SNR, dB
Signal to Noise Ratio
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jan 2017
- Primary completion1 Dec 2020
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Vision Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kaweh Mansouri, Swiss Vision Network
- Investigators
- Kaweh Mansouri, MD, Principal investigator, Glaucoma Center, Montchoisi Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330574
- Sponsor's protocol ID
- PERG-01
- Status last verified
- May 2022
- First submitted
- 12 Oct 2017
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Longitudinal Study to Evaluate the Function of the Retina and Visual Pathways in Glaucoma Patients Using PERG
- ClinicalTrials.gov ID
- NCT03330574
- Acronym / sponsor ID
- PERG-01
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Swiss Vision NetworkUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be enrolled from glaucoma clinics of the Montchoisi glaucoma center
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaweh Mansouri, MD principal investigator
Glaucoma Center, Montchoisi Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Swiss Vision Network at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude, μV (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.