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Hyperbaric Oxygen Therapy for Optic Neuropathy (HBOT Trial)

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be at least 18 years old
Participant with clinical evidence of optic neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 6 months

Summary

This trial tests if hyperbaric oxygen therapy can help protect vision in people with optic neuropathy.

Who is the study for?
This trial is for adults over 18 with optic neuropathy, who can follow the study's schedule and understand/sign the consent form. It's not suitable for those unable to meet these requirements or participate fully.
What is being tested?
The study tests hyperbaric oxygen therapy's ability to protect nerve cells in the eye from damage caused by optic neuropathy. Participants will either receive real or sham (fake) treatments to compare effectiveness.
What are the potential side effects?
Hyperbaric oxygen therapy may cause ear pressure, temporary nearsightedness, lung collapse due to air pressure changes, and rarely, oxygen poisoning which could lead to seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with optic neuropathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Visual Field- Mean Deviation
Change in Visual Field- Visual Field Index
Secondary study objectives
Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography
Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open LabelExperimental Treatment1 Intervention
Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial.
Group II: Active Hyperbaric OxygenExperimental Treatment1 Intervention
Participants will get Hyperbaric oxygen therapy for 20 days.
Group III: Sham Hyperbaric OxygenPlacebo Group1 Intervention
Participants will get a Sham Hyperbaric oxygen therapy for 20 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric Oxygen
2005
Completed Phase 3
~260

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,085 Total Patients Enrolled
Jeffrey L Goldberg, MD PhDStudy ChairStanford University
3 Previous Clinical Trials
95 Total Patients Enrolled
~10 spots leftby Jun 2025
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