HBOT: Hyperbaric Oxygen Therapy for Optic Neuropathies
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open Label Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial. |
Device: Hyperbaric Oxygen
Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen
|
| Experimental: Active Hyperbaric Oxygen Participants will get Hyperbaric oxygen therapy for 20 days. |
Device: Hyperbaric Oxygen
Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen
|
| Placebo Comparator: Sham Hyperbaric Oxygen Participants will get a Sham Hyperbaric oxygen therapy for 20 days |
Device: Sham Hyperbaric Oxygen
Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air.
|
Outcome Measures
Primary Outcome Measures
- Change in Visual Field- Mean Deviation [Baseline through 6 months]
Humphrey visual field testing with standard MD output
- Change in Visual Field- Visual Field Index [Baseline through 6 months]
Humphrey visual field testing with standard VFI output
Secondary Outcome Measures
- Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography [Baseline through 6 months]
OCT testing with standard GCC output
- Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography [Baseline through 6 months]
OCT testing with standard RNFL output
Eligibility Criteria
Criteria
Inclusion Criteria:
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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):
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Participant must be at least 18.
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Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
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Participant's with clinical evidence of optic neuropathy.
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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:
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Participant is unable to comply with study procedures or follow-up visits.
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Participant has evidence of corneal opacification or lack of optical clarity.
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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.
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Participant is pregnant or lactating.
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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.
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Children and comatose patients.
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Participant abusing drugs or alcohol.
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Prior treatment with hyperbaric oxygen within the last 6 months.
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Participant with claustrophobia or that cannot decompress properly.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Byers Eye Institute | Palo Alto | California | United States | 94303 |
Sponsors and Collaborators
- Stanford University
Investigators
- Study Chair: Jeffrey L Goldberg, MD PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 59547