Glaucoma, SuspectNCT06388096
CLAD Deconvolved PERG Responses in Glaucoma Patients
A study testing Pattern Electroretinogram in people with Glaucoma, Suspect, run by Jorvec Corp. at 1 site in United States.
Trial summary
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Suspect
- What is being tested?
- Pattern Electroretinogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Jun 2025
- Phase
- Interventional
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years, inclusive
- Refractive errors within -5 to +3 diopters
- Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
- Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on all global indices in two consecutive sessions 6 months apart)
- Minimum untreated Intraocular pressure IOP of 15 mm Hg
- Glaucoma Suspect Status defined as one or more of the following:
Show all 12Show fewer
- Glaucomatous optic disc appearance (vertical cup-to-disc ratio [C/D] ≥0.5
- Cup disc ratio asymmetry ≥0.2
- Localized thinning of the disc
- Presence or history of splinter disc hemorrhage
- Moderately increased IOP (>21 to <28 mm Hg).
- Family history of vision loss for glaucoma
Who cannot join
- Age-related macular degeneration
- Diabetes
- Parkinson's disease
- Multiple sclerosis
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- Pregnant or nursing women.
Show all 9Show fewer
- Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
- An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
- An OCT abnormal enough in a pattern consistent with glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street
Miami, Florida, 33136
Vittorio Porciatti, MD/PhD, vporciatti@med.miami.edu
About this study
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.
Read the detailed description
The PERG is recorded from small metallic cups taped on the skin or contact electrodes on the face similarly to an electrocardiogram except that the location is the skin around the eyes.
The only physical contact the subject will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test the subject will be asked to look at a visual stimulus display for about 3 minutes. Depending on the experimental protocol, the subject may be asked to either sit during the test or to lie down in a bed. Lying down will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases.
For OCT evaluation, the pupil will be dilated with drops similar to those used in a standard eye exam. The subject will have to briefly look at a mark inside the instrument one eye at a time.
For Visual field (VF) evaluation, the subject will be asked to look at a fixation mark inside the Visual Field testing equipment and asked to signal when they see small lights in their periphery.
PERG, OCT and VF will be performed during the same day of the visit. If the participant has already done these tests in the past, as part of another study or as part of standard treatment, the results of these tests will be obtained from shier record, and be included in this study.
RISKS:
For the PERG, the only significant risk to you is a small chance of skin discomfort from the cleansing agent for skin electrodes, which should go away without treatment. For OCT, there is a rare risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even lower if you did not have any reaction during your previous eye exams. In case of an allergic reaction, your eye doctor will immediately treat it. If you had previous problems with pupil dilation, you may wish to speak to your eye doctor about the option of doing this additional test. There are no significant risks associated with VF testing
- Conditions
- Glaucoma, Suspect
- Being tested
- Pattern Electroretinogram
- Keywords
- Glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pattern ElectroretinogramDiagnostic test
Non-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Suspects | Experimental | Patients with suspicion of glaucoma based on positive factors of disease. Receives: Diagnostic Test: Pattern Electroretinogram |
| Controls | Active comparator | Age matched controls to the glaucoma suspect group with no indications of glaucoma. Receives: Diagnostic Test: Pattern Electroretinogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
PERG Amplitude
Response amplitude measured in microvolts
Measured: Immediately after measurement
PERG Latency
Response feature latency in milliseconds following the stimulus delivery
Measured: Immediately after measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, SuspectStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jorvec Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388096
- Sponsor's protocol ID
- PERGCLAD001
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals. In addition, a de-identified database containing subject gender, age at recording, raw localization and tracking data, will be maintained. The data will be shared with other centers conducting similar research under appropriate IRB approval.
Publications
Porciatti V, Feuer WJ, Monsalve P, Triolo G, Vazquez L, McSoley J, Ventura LM. Head-down Posture in Glaucoma Suspects Induces Changes in IOP, Systemic Pressure, and PERG That Predict Future Loss of Optic Nerve Tissue. J Glaucoma. 2017 May;26(5):459-465. doi: 10.1097/IJG.0000000000000648.
PubMed 28263259Porciatti V, Chou TH. Modeling Retinal Ganglion Cell Dysfunction in Optic Neuropathies. Cells. 2021 Jun 5;10(6):1398. doi: 10.3390/cells10061398.
PubMed 34198840Monsalve P, Ren S, Triolo G, Vazquez L, Henderson AD, Kostic M, Gordon P, Feuer WJ, Porciatti V. Steady-state PERG adaptation: a conspicuous component of response variability with clinical significance. Doc Ophthalmol. 2018 Jun;136(3):157-164. doi: 10.1007/s10633-018-9633-2. Epub 2018 May 19.
PubMed 29779071Monsalve P, Triolo G, Toft-Nielsen J, Bohorquez J, Henderson AD, Delgado R, Miskiel E, Ozdamar O, Feuer WJ, Porciatti V. Next Generation PERG Method: Expanding the Response Dynamic Range and Capturing Response Adaptation. Transl Vis Sci Technol. 2017 May 22;6(3):5. doi: 10.1167/tvst.6.3.5. eCollection 2017 May.
PubMed 28553559Toft-Nielsen J, Bohorquez J, Ozdamar O. Unwrapping of transient responses from high rate overlapping pattern electroretinograms by deconvolution. Clin Neurophysiol. 2014 Oct;125(10):2079-89. doi: 10.1016/j.clinph.2014.02.002. Epub 2014 Feb 14.
PubMed 24618216Ozdamar O, Toft-Nielsen J, Bohorquez J, Porciatti V. Relationship between transient and steady-state pattern electroretinograms: theoretical and experimental assessment. Invest Ophthalmol Vis Sci. 2014 Dec 4;55(12):8560-70. doi: 10.1167/iovs.14-15685.
PubMed 25477321
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLAD Deconvolved PERG Responses in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT06388096
- Acronym / sponsor ID
- PERGCLAD001
- Conditions
- Glaucoma, Suspect
- Keywords
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jorvec Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Apr 2024 (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.
Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls.
Detailed description
The PERG is recorded from small metallic cups taped on the skin or contact electrodes on the face similarly to an electrocardiogram except that the location is the skin around the eyes.
The only physical contact the subject will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test the subject will be asked to look at a visual stimulus display for about 3 minutes. Depending on the experimental protocol, the subject may be asked to either sit during the test or to lie down in a bed. Lying down will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases.
For OCT evaluation, the pupil will be dilated with drops similar to those used in a standard eye exam. The subject will have to briefly look at a mark inside the instrument one eye at a time.
For Visual field (VF) evaluation, the subject will be asked to look at a fixation mark inside the Visual Field testing equipment and asked to signal when they see small lights in their periphery.
PERG, OCT and VF will be performed during the same day of the visit. If the participant has already done these tests in the past, as part of another study or as part of standard treatment, the results of these tests will be obtained from shier record, and be included in this study.
RISKS:
For the PERG, the only significant risk to you is a small chance of skin discomfort from the cleansing agent for skin electrodes, which should go away without treatment. For OCT, there is a rare risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even lower if you did not have any reaction during your previous eye exams. In case of an allergic reaction, your eye doctor will immediately treat it. If you had previous problems with pupil dilation, you may wish to speak to your eye doctor about the option of doing this additional test. There are no significant risks associated with VF testing
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Suspects | Experimental | Diagnostic Test: Pattern ElectroretinogramPatients with suspicion of glaucoma based on positive factors of disease. |
| Controls | Active comparator | Diagnostic Test: Pattern ElectroretinogramAge matched controls to the glaucoma suspect group with no indications of glaucoma. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 85 years, inclusive
- Refractive errors within -5 to +3 diopters
- Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
- Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability < 15% on all indices, normality > 5% on all global indices in two consecutive sessions 6 months apart)
- Minimum untreated Intraocular pressure IOP of 15 mm Hg
Key exclusion criteria (9 listed)
- Age-related macular degeneration
- Diabetes
- Parkinson's disease
- Multiple sclerosis
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pattern ElectroretinogramNon-invasive recording of retinal potentials from a modulating pattern stimulus viewed on a visual display and recorded from surface electrodes around the eye. | Diagnostic test | Controls, Glaucoma Suspects |
Primary outcome
PERG Amplitude
Time frame: Immediately after measurement
Response amplitude measured in microvolts
PERG Latency
Time frame: Immediately after measurement
Response feature latency in milliseconds following the stimulus delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 28263259Porciatti V, Feuer WJ, Monsalve P, Triolo G, Vazquez L, McSoley J, Ventura LM. Head-down Posture in Glaucoma Suspects Induces Changes in IOP, Systemic Pressure, and PERG That Predict Future Loss of Optic Nerve Tissue. J Glaucoma. 2017 May;26(5):459-465. doi: 10.1097/IJG.0000000000000648.
- Background: PubMed 34198840Porciatti V, Chou TH. Modeling Retinal Ganglion Cell Dysfunction in Optic Neuropathies. Cells. 2021 Jun 5;10(6):1398. doi: 10.3390/cells10061398.
- Background: PubMed 29779071Monsalve P, Ren S, Triolo G, Vazquez L, Henderson AD, Kostic M, Gordon P, Feuer WJ, Porciatti V. Steady-state PERG adaptation: a conspicuous component of response variability with clinical significance. Doc Ophthalmol. 2018 Jun;136(3):157-164. doi: 10.1007/s10633-018-9633-2. Epub 2018 May 19.
- Background: PubMed 28553559Monsalve P, Triolo G, Toft-Nielsen J, Bohorquez J, Henderson AD, Delgado R, Miskiel E, Ozdamar O, Feuer WJ, Porciatti V. Next Generation PERG Method: Expanding the Response Dynamic Range and Capturing Response Adaptation. Transl Vis Sci Technol. 2017 May 22;6(3):5. doi: 10.1167/tvst.6.3.5. eCollection 2017 May.
- Background: PubMed 24618216Toft-Nielsen J, Bohorquez J, Ozdamar O. Unwrapping of transient responses from high rate overlapping pattern electroretinograms by deconvolution. Clin Neurophysiol. 2014 Oct;125(10):2079-89. doi: 10.1016/j.clinph.2014.02.002. Epub 2014 Feb 14.
- Background: PubMed 25477321Ozdamar O, Toft-Nielsen J, Bohorquez J, Porciatti V. Relationship between transient and steady-state pattern electroretinograms: theoretical and experimental assessment. Invest Ophthalmol Vis Sci. 2014 Dec 4;55(12):8560-70. doi: 10.1167/iovs.14-15685.
- Individual participant dataSharing planned: Yes. The results from the project will be shared by presenting results at scientific conferences and publishing results in scientific journals. In addition, a de-identified database containing subject gender, age at recording, raw localization and tracking data, will be maintained. The data will be shared with other centers conducting similar research under appropriate IRB approval.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pattern Electroretinogram in people with Glaucoma, Suspect, run by Jorvec Corp. at 1 site in United States.
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 12 inclusion and 9 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 16 May 2024. 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 United States. 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?
Contact Jonathon A Toft-Nielsen, PhD (305-668-6102 ext. 35, jtoftnielsen@jorvec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERG Amplitude (time frame: Immediately after measurement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06388096, which also lists 6 linked publications.
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 16 May 2024.