Hyperbaric Oxygen Therapy for Optic Neuropathies (HBOT)

A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy

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

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Optic Neuropathy
• Intervention / Treatment: Device: Hyperbaric Oxygen; Device: Sham Hyperbaric Oxygen

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zac Wennberg Smith; Phone Number: 6504975942; Email: zacwenn@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Byers Eye Institute
      • Contact: Zac Wennberg-Smith; Phone Number: 650-497-5942; Email: zacwenn@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	OCT testing with standard RNFL output	Baseline through 6 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Chair: Jeffrey L Goldberg, MD PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Optic Nerve Diseases
• Other Study ID Numbers: 59547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes