GlaucomaNCT04433702
Effect of Negative Pressure on Pattern Electroretinography Readings
A study testing Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle in people with Glaucoma and Open Angle, Low Risk, run by Vance Thompson Vision at 1 site in United States.
Trial summary
Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) remains the only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma induces retinal ganglion cell death and visual field loss. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glaucoma, Open Angle, Low Risk, Ocular Hypertension
- What is being tested?
- Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Dec 2020
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects capable of committing to the duration of the study and signing the informed consent.
- Subjects must be male or female and ≥ 22 years of age at the time of signing the informed consent.
- Subjects with orbital anatomy that permits a proper seal when goggles are placed over eyes.
- Subjects can tolerate ERG measurements.
- Subjects with a documented BCVA OU 20/40 or better AND a diagnosis of OHT, glaucoma suspect, or OAG in both eyes. OAG definition is inclusive of normal tension glaucoma, pseudoexfoliation glaucoma, and pigment dispersion. Both eyes require same diagnosis.
- Subjects with prior surgeries such as refractive surgeries (e.g., LASIK, PRK, SMILE), cataract surgery, cataract surgery with minimally invasive glaucoma surgery (MIGS), MIGS alone, trabeculectomy, or implantation of other glaucoma drainage devices can be included in the study; however, no other prior ocular surgeries are permitted.
- Subjects without lenticular opacities and/or trace (i.e. 1+) lenticular opacities.
Who cannot join
- Subjects with a history of allergy to primary study device material (i.e. silicone, anti-fog solution).
- Subjects with a history of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or subject safety (e.g., corneal transplant).
- Subjects with a history of any demyelinating disorder or condition that would likely interfere with the interpretation of the study results or subject safety (e.g. MS).
- Subjects with an untreated retinal detachment, retinal tears, macular degeneration, or any other fundus findings that may prevent accurate ERG measurements in either eye.
- Subjects with conjunctival chemosis in either eye.
- Subjects with eyelid edema.
Show all 9Show fewer
- Subjects with a history of seizure disorder.
- Subjects with an eye infection.
- Subjects with moderate-severe (i.e. 2+, 3+, or 4+) lenticular opacities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: A Controlled, Open-Label, Randomized Study to Evaluate the Application of Negative Pressure to the Periocular Microenvironment to Alter Pattern Electroretinography Readings by Way of Modulating Intraocular Pressure
Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) remains the only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma induces retinal ganglion cell death and visual field loss. Pattern electroretinography (pERG) measurements directly correlate with retinal ganglion cell (RGC) signaling, providing an objective, repeatable, and non-invasive assessment of RGC function. The purpose of the study is to investigate the pERG changes associated with acute IOP reduction using the Mercury™ Multi-Pressure Dial (MPD). 10 patients will be enrolled. These subjects will have a best corrected visual acuity of 20/40 or better in both eyes and an established diagnosis of one of either mild/moderate OAG (open-angle glaucoma), OHT (ocular hypertension), or glaucoma suspect. Both eyes will be enrolled in the study. The study eye will receive a standardized 10 mmHg decrease in periorbital pressure via the Mercury™ Multi-Pressure Dial (MPD), and the fellow/control eye will receive no (zero) pressure application. Total google wear time will be 4.5 hours. Serial pERG measurements will be taken before, immediately after, and 2 hours after negative pressure application.
- Conditions
- Glaucoma, Open Angle, Low Risk, Ocular Hypertension, Glaucoma Suspect
- Being tested
- Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle, Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle
- Keywords
- glaucoma treatment, multi-pressure dial, pattern electroretinography, open-angle glaucoma
- Medical subject headings
- Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mercury™ Multi-Pressure Dial (MPD) Experimental GoggleDevice
The Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial.
The Mercury™ MPD consists of:
- Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.
- Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
Mercury™ Multi-Pressure Dial (MPD) Placebo GoggleDevice
The Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial.
The Mercury™ MPD consists of:
- Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.
- Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
| Study group | Role | What they receive |
|---|---|---|
| Experimental Eye | Experimental | 10 mmHg of negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that only one goggle receives negative pressure. Receives: Device: Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle |
| Control Eye | Placebo comparator | The opposing eye serves as the intrasubject control for each participant. No negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that the other goggle does not receive negative pressure. Receives: Device: Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern Electroretinography (pERG) Alterations
Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim.
Measured: 0 hours; 4.5 hours; 6.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Oct 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Changed the study design and opened a new study
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vance Thompson Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Greenwood, MD, Principal investigator, Vance Thompson Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433702
- Sponsor's protocol ID
- CP-014
- Status last verified
- May 2024
- First submitted
- 11 Jun 2020
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Open-Label, Randomized Study to Evaluate the Application of Negative Pressure to the Periocular Microenvironment to Alter Pattern Electroretinography Readings by Way of Modulating Intraocular Pressure
- ClinicalTrials.gov ID
- NCT04433702
- Acronym / sponsor ID
- CP-014
- Conditions
- Glaucoma, Open Angle, Low Risk, Ocular Hypertension, Glaucoma Suspect
- Keywords
- glaucoma treatment, multi-pressure dial, pattern electroretinography, open-angle glaucoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changed the study design and opened a new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vance Thompson VisionUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Jun 2020 (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 leading cause of blindness worldwide. Intraocular pressure (IOP) remains the only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma induces retinal ganglion cell death and visual field loss. Pattern electroretinography (pERG) measurements directly correlate with retinal ganglion cell (RGC) signaling, providing an objective, repeatable, and non-invasive assessment of RGC function. The purpose of the study is to investigate the pERG changes associated with acute IOP reduction using the Mercury™ Multi-Pressure Dial (MPD). 10 patients will be enrolled. These subjects will have a best corrected visual acuity of 20/40 or better in both eyes and an established diagnosis of one of either mild/moderate OAG (open-angle glaucoma), OHT (ocular hypertension), or glaucoma suspect. Both eyes will be enrolled in the study. The study eye will receive a standardized 10 mmHg decrease in periorbital pressure via the Mercury™ Multi-Pressure Dial (MPD), and the fellow/control eye will receive no (zero) pressure application. Total google wear time will be 4.5 hours. Serial pERG measurements will be taken before, immediately after, and 2 hours after negative pressure application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Eye | Experimental | Device: Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle10 mmHg of negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that only one goggle receives negative pressure. |
| Control Eye | Placebo comparator | Device: Mercury™ Multi-Pressure Dial (MPD) Placebo GoggleThe opposing eye serves as the intrasubject control for each participant. No negative pressure is applied to the periocular microenvironment. This is achieved by programming the Mercury™ Multi-Pressure Dial (MPD) such that the other goggle does not receive negative pressure. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects capable of committing to the duration of the study and signing the informed consent.
- Subjects must be male or female and ≥ 22 years of age at the time of signing the informed consent.
- Subjects with orbital anatomy that permits a proper seal when goggles are placed over eyes.
- Subjects can tolerate ERG measurements.
- Subjects with a documented BCVA OU 20/40 or better AND a diagnosis of OHT, glaucoma suspect, or OAG in both eyes. OAG definition is inclusive of normal tension glaucoma, pseudoexfoliation glaucoma, and pigment dispersion. Both eyes require same diagnosis.
Key exclusion criteria (9 listed)
- Subjects with a history of allergy to primary study device material (i.e. silicone, anti-fog solution).
- Subjects with a history of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or subject safety (e.g., corneal transplant).
- Subjects with a history of any demyelinating disorder or condition that would likely interfere with the interpretation of the study results or subject safety (e.g. MS).
- Subjects with an untreated retinal detachment, retinal tears, macular degeneration, or any other fundus findings that may prevent accurate ERG measurements in either eye.
- Subjects with conjunctival chemosis in either eye.
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 |
|---|---|---|
| Mercury™ Multi-Pressure Dial (MPD) Experimental GoggleThe Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial. The Mercury™ MPD consists of: 1. Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump. 2. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device | Device | Experimental Eye |
| Mercury™ Multi-Pressure Dial (MPD) Placebo GoggleThe Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial. The Mercury™ MPD consists of: 1. Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump. 2. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device | Device | Control Eye |
Primary outcome
Pattern Electroretinography (pERG) Alterations
Time frame: 0 hours; 4.5 hours; 6.5 hours
Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- 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.
Michael Greenwood, MD principal investigator
Vance Thompson Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle in people with Glaucoma and Open Angle, Low Risk, run by Vance Thompson Vision 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 7 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: withdrawn, as of the sponsor's last update on 20 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pattern Electroretinography (pERG) Alterations (time frame: 0 hours; 4.5 hours; 6.5 hours). 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 20 May 2024.