NCT06128720 · Stanford University
Hyperbaric Oxygen Therapy for Optic Neuropathies
(HBOT)
What this study is about
The purpose of the study is to evaluate the neuroprotective effectiveness of hyperbaric oxygen for the treatment in patients with optic neuropathy.
View original scientific description
The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.
Interventions
DEVICE
Hyperbaric Oxygen
Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen
DEVICE
Sham Hyperbaric Oxygen
Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Participant abusing drugs or alcohol.
- Prior treatment with hyperbaric oxygen within the last 6 months.
- Participant with claustrophobia or that cannot decompress properly.
Where
- Palo Alto, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 25, 2025 · Source of record for eligibility and locations