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The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Experimental | Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial. |
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| Active Hyperbaric Oxygen | Experimental | Participants will get Hyperbaric oxygen therapy for 20 days. |
|
| Sham Hyperbaric Oxygen | Placebo Comparator | Participants will get a Sham Hyperbaric oxygen therapy for 20 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen | Device | Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Field- Mean Deviation | Humphrey visual field testing with standard MD output | Baseline through 6 months |
| Change in Visual Field- Visual Field Index | Humphrey visual field testing with standard VFI output | Baseline through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography | OCT testing with standard GCC output | Baseline through 6 months |
| Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zac Wennberg Smith | Contact | 6504975942 | zacwenn@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD PhD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute | Recruiting | Palo Alto | California | 94303 | United States |
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| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| Sham Hyperbaric Oxygen | Device | Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air. |
|
OCT testing with standard RNFL output
| Baseline through 6 months |