Randomized Study to Test Neuroprotective Effects of Hyperbaric Oxygen Therapy in Adults with Optic Neuropathy

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 treatments 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.

Hyperbaric Oxygen Therapy for Optic Neuropathies