Actively Recruiting
A Randomized, Sham Controlled, Masked Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy
Led by Stanford University · Updated on 2025-05-25
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the neuroprotective effects of hyperbaric oxygen therapy for patients with optic neuropathy, including glaucoma. The study aims to determine whether this treatment can help protect the nerves related to vision. It is a randomized, single-masked phase II trial sponsored by Stanford University to better understand the treatment's impact on vision over time. Participants will be randomly assigned to one of three groups: one group will receive 20 days of hyperbaric oxygen therapy at 1.5 ATA breathing 100% oxygen for 60 minutes per session, another group will receive the same hyperbaric oxygen therapy for 20 days without masking, and a third group will receive sham hyperbaric oxygen therapy at atmospheric pressure breathing room air for 60 minutes daily over 20 days. This design helps compare the effects of the real therapy against a placebo. Participants will be monitored through baseline and follow-up visits up to 6 months to evaluate changes in visual field mean deviation and visual field index as primary outcomes. Secondary outcomes include changes in retinal nerve fiber layer and ganglion cell complex thickness measured by optical coherence tomography. The study involves adherence to scheduled visits and assessments to track vision and nerve structure changes, ensuring participant safety and data collection throughout the study period.
CONDITIONS
Brief Title
Hyperbaric Oxygen Therapy for Optic Neuropathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 18 years old.
- Participant must have clinical evidence of optic neuropathy.
- Participant must be able to comply with study requirements and complete scheduled visits.
- Participant must understand and sign informed consent, with assistance if vision impaired.
You will not qualify if you...
- Participant unable to comply with study procedures or follow-up visits.
- Evidence of corneal opacification or lack of optical clarity.
- Participation in another ocular or systemic drug trial within the last 3 months.
- Pregnancy or lactation.
- Physical or mental conditions increasing risk or interfering with study.
- Children and comatose patients.
- Drug or alcohol abuse.
- Hyperbaric oxygen treatment within the last 6 months.
- Claustrophobia or inability to decompress properly.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 days
Participants receive Hyperbaric Oxygen or Sham Hyperbaric Oxygen therapy for 60 minutes daily over 20 days.
Daily visits for 20 days
Trial Site Locations
Total: 1 location
1
Byers Eye Institute
Palo Alto, California, United States, 94303
Actively Recruiting
Research Team
Z
Zac Wennberg Smith
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here