Hyperbaric Oxygen Therapy for Optic Neuropathies

Not Applicable

Recruiting

• Conditions: Glaucoma; Optic Neuropathy
• Interventions: Device: Hyperbaric Oxygen; Device: Sham Hyperbaric Oxygen

• Registration Number: NCT06128720
• Lead Sponsor: Stanford University

Brief Summary

The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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):
• Participant must be at least 18.
• Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
• Participant's with clinical evidence of optic neuropathy.
• 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

• Participant is unable to comply with study procedures or follow-up visits.
• Participant has evidence of corneal opacification or lack of optical clarity.
• 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.
• Participant is pregnant or lactating.
• 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.
• Children and comatose patients.
• Participant abusing drugs or alcohol.
• Prior treatment with hyperbaric oxygen within the last 6 months.
• Participant with claustrophobia or that cannot decompress properly.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Label	Hyperbaric Oxygen	Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial.
Active Hyperbaric Oxygen	Hyperbaric Oxygen	Participants will get Hyperbaric oxygen therapy for 20 days.
Sham Hyperbaric Oxygen	Sham Hyperbaric Oxygen	Participants will get a Sham Hyperbaric oxygen therapy for 20 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography	Baseline through 6 months	OCT testing with standard RNFL output
Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography	Baseline through 6 months	OCT testing with standard GCC output

Trial Locations

Locations (1)

Byers Eye Institute; 🇺🇸 Palo Alto, California, United States