GlaucomaPhase 1NCT04035239
Retinal Effects of Balance Goggles System in Glaucoma Balance Goggles System (BGS) in Patients With Glaucoma
A Phase 1 study testing BGS goggles in people with Glaucoma and Ocular Hypertension, run by Stanford University at 1 site in United States.
Trial summary
This is an open-label trial of 20 study participants with glaucoma or ocular hypertension. Participants with qualifying study eye(s) after screening and baseline evaluations will receive the Balance Goggles System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- BGS goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2019to 28 Mar 2022
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be medically able to undergo the testing required in the schedule of events (SOE).
- Participant's clinical diagnosis must be consistent with glaucoma characterized by clinical evidence of progressive retinal ganglion cell dysfunction and degeneration using at least one visual field and at least one structural modality, OR with ocular hypertension with intraocular pressure above 21 mm Hg.
- If a participant has two eyes meeting study criteria, both may be enrolled.
- Subjects with orbital anatomy that permits a proper seal in both eyes when goggles are placed over eyes and can tolerate measurements with goggles in place
- Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
Who cannot join
- Subjects with a history of allergy to primary study device material (i.e., silicone)
- Subjects with a history of any ocular disorder or condition (e.g., corneal transplant) in either eye that would likely interfere with the interpretation of the study results or compromise subject safety
- Subjects with a prior retinal detachment, active retinal detachment, an untreated retinal detachment, unresolved cystoid macular edema, or any other fundus findings that may prevent visualization of the retina in either eye; subjects with macular degeneration are not excluded from participation in the study
- Subjects with a history of prior penetrating glaucoma surgery (e.g. trabeculectomy, tube shunt, etc.) in either eye
- Subjects with narrow anterior chamber angle anatomy in either eye as visualized by gonioscopy with a Shaffer angle grade of ≤ 2 in any of the four quadrants
- Subjects with eyelid edema, festoons or excessive skin laxity in either eye
Show all 11Show fewer
- Subjects with conjunctival chemosis in either eye
- Subjects with best corrected visual acuity of 20/200 or worse in either eye due to glaucoma
- Subjects who have had intraocular surgery in the study eye within 12 weeks prior to the screening visit , or who, in the opinion of the investigator, may require any ocular surgery (e.g., cataract extraction or glaucoma procedure) in either eye during the course of the study
- Subjects who do not wish to or cannot comply with study procedures, including home use of the study device
- Subjects with any physical or mental condition that would, in the opinion of the investigator, increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
About this study
Official title: An Open-Label Phase Ib Study to Evaluate Retinal Imaging After Short-term Use of the Balance Goggles System (BGS) in Patients With Glaucoma
This is an open-label trial of 20 study participants with glaucoma or ocular hypertension. Participants with qualifying study eye(s) after screening and baseline evaluations will receive the Balance Goggles System. After a baseline evaluation (prior to negative pressure application through the BGS), study eyes will be treated for one hour in the clinic and be evaluated again. They will then use the BGS for the next 3-6 weeks and be evaluated again. The goal is to determine whether the intraocular pressure (IOP)-lowering effects of BGS is accompanied by changes in retinal thickness measured by optical coherence tomography (OCT), retinal vascular density measured by OCT-angiography, or retinal fluorescence measured by a fundus camera.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- BGS goggles
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGS gogglesDevice
BGS goggles use for 3-6 weeks
| Study group | Role | What they receive |
|---|---|---|
| BGS use | Experimental | Use of BGS goggles for a 3-6 weeks period. Receives: Device: BGS goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal thickness
Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography imaging
Measured: Over a 3-6 week treatment period to study completion
Retinal vascular density
Change from baseline in vessel density measured by optical coherence tomographic angiography imaging
Measured: Over a 3-6 week treatment period to study completion
Retinal fluorescence
Change from baseline in flavoprotein fluorescence measured by fundus photography imaging
Measured: Over a 3-6 week treatment period to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start23 Jul 2019
- Primary completion28 Feb 2020
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035239
- Sponsor's protocol ID
- 50800
- Status last verified
- Nov 2022
- First submitted
- 23 Jul 2019
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Sun MT, Beykin G, Lee WS, Sun Y, Chang R, Nunez M, Li KZ, Knasel C, Rich C, Goldberg JL. Structural and Metabolic Imaging After Short-term Use of the Balance Goggles System in Glaucoma Patients: A Pilot Study. J Glaucoma. 2022 Aug 1;31(8):634-638. doi: 10.1097/IJG.0000000000002066. Epub 2022 Jun 13.
PubMed 35696700
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase Ib Study to Evaluate Retinal Imaging After Short-term Use of the Balance Goggles System (BGS) in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT04035239
- Acronym / sponsor ID
- 50800
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 29 Jul 2019 (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.
This is an open-label trial of 20 study participants with glaucoma or ocular hypertension. Participants with qualifying study eye(s) after screening and baseline evaluations will receive the Balance Goggles System. After a baseline evaluation (prior to negative pressure application through the BGS), study eyes will be treated for one hour in the clinic and be evaluated again. They will then use the BGS for the next 3-6 weeks and be evaluated again. The goal is to determine whether the intraocular pressure (IOP)-lowering effects of BGS is accompanied by changes in retinal thickness measured by optical coherence tomography (OCT), retinal vascular density measured by OCT-angiography, or retinal fluorescence measured by a fundus camera.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BGS use | Experimental | Device: BGS gogglesUse of BGS goggles for a 3-6 weeks period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be medically able to undergo the testing required in the schedule of events (SOE).
- Participant's clinical diagnosis must be consistent with glaucoma characterized by clinical evidence of progressive retinal ganglion cell dysfunction and degeneration using at least one visual field and at least one structural modality, OR with ocular hypertension with intraocular pressure above 21 mm Hg.
- If a participant has two eyes meeting study criteria, both may be enrolled.
- Subjects with orbital anatomy that permits a proper seal in both eyes when goggles are placed over eyes and can tolerate measurements with goggles in place
- Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
Key exclusion criteria (11 listed)
- Subjects with a history of allergy to primary study device material (i.e., silicone)
- Subjects with a history of any ocular disorder or condition (e.g., corneal transplant) in either eye that would likely interfere with the interpretation of the study results or compromise subject safety
- Subjects with a prior retinal detachment, active retinal detachment, an untreated retinal detachment, unresolved cystoid macular edema, or any other fundus findings that may prevent visualization of the retina in either eye; subjects with macular degeneration are not excluded from participation in the study
- Subjects with a history of prior penetrating glaucoma surgery (e.g. trabeculectomy, tube shunt, etc.) in either eye
- Subjects with narrow anterior chamber angle anatomy in either eye as visualized by gonioscopy with a Shaffer angle grade of ≤ 2 in any of the four quadrants
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 |
|---|---|---|
| BGS gogglesBGS goggles use for 3-6 weeks | Device | BGS use |
Primary outcome
Retinal thickness
Time frame: Over a 3-6 week treatment period to study completion
Change from baseline in retinal nerve fiber layer thickness measured by optical coherence tomography imaging
Retinal vascular density
Time frame: Over a 3-6 week treatment period to study completion
Change from baseline in vessel density measured by optical coherence tomographic angiography imaging
Retinal fluorescence
Time frame: Over a 3-6 week treatment period to study completion
Change from baseline in flavoprotein fluorescence measured by fundus photography imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Results publication: PubMed 35696700Sun MT, Beykin G, Lee WS, Sun Y, Chang R, Nunez M, Li KZ, Knasel C, Rich C, Goldberg JL. Structural and Metabolic Imaging After Short-term Use of the Balance Goggles System in Glaucoma Patients: A Pilot Study. J Glaucoma. 2022 Aug 1;31(8):634-638. doi: 10.1097/IJG.0000000000002066. Epub 2022 Jun 13.
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGS goggles in people with Glaucoma and Ocular Hypertension, run by Stanford University 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 23 Nov 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Retinal thickness (time frame: Over a 3-6 week treatment period to study completion). The study lists 3 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 NCT04035239, which also lists 1 linked publication.
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 23 Nov 2022.