Using hyperbaric oxygen therapy to treat optic neuropathies
A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy
This study is testing if hyperbaric oxygen therapy can help improve vision and eye health for adults with optic neuropathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06128720 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hyperbaric oxygen therapy in providing neuroprotection for patients suffering from optic neuropathy. Participants will receive either hyperbaric oxygen treatment or a sham treatment to assess the potential benefits of the therapy. The study aims to determine if this innovative approach can improve vision and overall eye health in affected individuals. Eligible participants must be at least 18 years old and have clinical evidence of optic neuropathy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with clinical evidence of optic neuropathy.
Not a fit: Patients with corneal opacification or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment option for patients with optic neuropathy, potentially improving their vision and quality of life.
How similar studies have performed: While hyperbaric oxygen therapy has been explored in various contexts, its application specifically for optic neuropathies is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- Byers Eye Institute — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Zac Wennberg Smith
- Email: zacwenn@stanford.edu
- Phone: 6504975942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.