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Recruiting

NCT Number: NCT06128720

Hyperbaric Oxygen Therapy for Optic Neuropathies

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute

Palo Alto, California, 94303, United States

Location status: Recruiting

Location contact

Zac Wennberg-Smith

CONTACT

[email protected]

650-497-5942

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyperbaric oxygen

Device

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

Sham Hyperbaric Oxygen

Device

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

Primary outcomes

  1. Change in Visual Field- Mean Deviation

    Time frame: Baseline through 6 months

    Humphrey visual field testing with standard MD output

  2. Change in Visual Field- Visual Field Index

    Time frame: Baseline through 6 months

    Humphrey visual field testing with standard VFI output

Secondary outcomes

  1. Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography

    Time frame: Baseline through 6 months

    OCT testing with standard GCC output

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

    Time frame: Baseline through 6 months

    OCT testing with standard RNFL output

Study contacts

Contact information is provided by the study sponsor or research team.

Zac Wennberg Smith

CONTACT

[email protected]

6504975942

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: HBOT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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