Optic NeuropathyHBOTNCT06128720
Hyperbaric Oxygen Therapy for Optic Neuropathies
A study testing Hyperbaric Oxygen in people with Optic Neuropathy and Glaucoma, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Neuropathy, Glaucoma
- What is being tested?
- Hyperbaric Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
- Participant must be at least 18.
- Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
- Participant's with clinical evidence of optic neuropathy.
- 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
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has evidence of corneal opacification or lack of optical clarity.
- Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
- Participant is pregnant or lactating.
- Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
- Children and comatose patients.
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- Participant abusing drugs or alcohol.
- Prior treatment with hyperbaric oxygen within the last 6 months.
- Participant with claustrophobia or that cannot decompress properly.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Byers Eye Institute
Palo Alto, California, 94303
Zac Wennberg-Smith, 650-497-5942, zacwenn@stanford.edu
About this study
Official title: A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy
The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.
- Conditions
- Optic Neuropathy, Glaucoma
- Being tested
- Hyperbaric Oxygen, Sham Hyperbaric Oxygen
- Medical subject headings
- Optic Nerve Diseases, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenDevice
Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen
Sham Hyperbaric OxygenDevice
Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial. Receives: Device: Hyperbaric Oxygen |
| Active Hyperbaric Oxygen | Experimental | Participants will get Hyperbaric oxygen therapy for 20 days. Receives: Device: Hyperbaric Oxygen |
| Sham Hyperbaric Oxygen | Placebo comparator | Participants will get a Sham Hyperbaric oxygen therapy for 20 days Receives: Device: Sham Hyperbaric Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Field- Mean Deviation
Humphrey visual field testing with standard MD output
Measured: Baseline through 6 months
Change in Visual Field- Visual Field Index
Humphrey visual field testing with standard VFI output
Measured: Baseline through 6 months
Secondary outcomes (2)
Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography
OCT testing with standard GCC output
Measured: Baseline through 6 months
Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography
OCT testing with standard RNFL output
Measured: Baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2022
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD PhD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128720
- Sponsor's protocol ID
- 59547
- Acronym
- HBOT
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2023
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy
- ClinicalTrials.gov ID
- NCT06128720
- Acronym / sponsor ID
- HBOT / 59547
- Conditions
- Optic Neuropathy, Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Nov 2023 (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 the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Device: Hyperbaric OxygenParticipants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial. |
| Active Hyperbaric Oxygen | Experimental | Device: Hyperbaric OxygenParticipants will get Hyperbaric oxygen therapy for 20 days. |
| Sham Hyperbaric Oxygen | Placebo comparator | Device: Sham Hyperbaric OxygenParticipants will get a Sham Hyperbaric oxygen therapy for 20 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
- Participant must be at least 18.
- Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
- Participant's with clinical evidence of optic neuropathy.
- 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 (9 listed)
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has evidence of corneal opacification or lack of optical clarity.
- Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
- Participant is pregnant or lactating.
- Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
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 |
|---|---|---|
| Hyperbaric OxygenParticipant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen | Device | Active Hyperbaric Oxygen, Open Label |
| Sham Hyperbaric OxygenParticipant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air. | Device | Sham Hyperbaric Oxygen |
Primary outcome
Change in Visual Field- Mean Deviation
Time frame: Baseline through 6 months
Humphrey visual field testing with standard MD output
Change in Visual Field- Visual Field Index
Time frame: Baseline through 6 months
Humphrey visual field testing with standard VFI output
2 secondary outcomes
Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography
Time frame: Baseline through 6 months
Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography
Time frame: Baseline through 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- 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.
Jeffrey L Goldberg, MD PhD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen in people with Optic Neuropathy and Glaucoma, 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 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zac Wennberg Smith (6504975942, zacwenn@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Field- Mean Deviation (time frame: Baseline through 6 months). 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?
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 9 Oct 2026.