Hyperbaric Oxygen Therapy for Optic Neuropathies

NCT06128720 | Recruiting FDA Device

• 1 other identifier: 59547
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Optic Neuropathy; Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography

  Baseline through 6 months

• Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography

  Baseline through 6 months

Study Arms (3)

Open Label

EXPERIMENTAL

Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial.

Device: Hyperbaric Oxygen

Active Hyperbaric Oxygen

EXPERIMENTAL

Participants will get Hyperbaric oxygen therapy for 20 days.

Device: Hyperbaric Oxygen

Sham Hyperbaric Oxygen

PLACEBO COMPARATOR

Participants will get a Sham Hyperbaric oxygen therapy for 20 days

Device: Sham Hyperbaric Oxygen

Interventions

Hyperbaric Oxygen DEVICE

Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen

Active Hyperbaric Oxygen; Open Label

Sham Hyperbaric Oxygen DEVICE

Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air.

Sham Hyperbaric Oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Optic Nerve Diseases; Glaucoma

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Jeffrey L Goldberg, MD PhD

  Stanford University

  STUDY CHAIR

Central Study Contacts

Zac Wennberg Smith

CONTACT

6504975942; zacwenn@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)