Recruiting

Hyperbaric Oxygen Therapy

Sponsor:

Stanford University

Code:

NCT06128720

Conditions

Optic Neuropathy

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen

Sham Hyperbaric Oxygen

Study Details

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

Study ID

NCT06128720

Start date

Nov 1, 2022

Status verified date

May, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Label

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

experimental: Active Hyperbaric Oxygen

Participants will get Hyperbaric oxygen therapy for 20 days.

placebo comparator: Sham Hyperbaric Oxygen

Participants will get a Sham Hyperbaric oxygen therapy for 20 days

Interventions

Hyperbaric Oxygen

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

Sham Hyperbaric Oxygen

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

Primary outcome measure

  • Change in Visual Field- Mean Deviation [ Time Frame: Baseline through 6 months ]
  • Change in Visual Field- Visual Field Index [ Time Frame: Baseline through 6 months ]

Central Contacts and Locations

Central contacts

Zac Wennberg Smith

6504975942zacwenn@stanford.edu

Locations

Byers Eye Institute

Recruiting

Palo Alto, California, United States, 94303

Contacts

Zac Wennberg-Smith

650-497-5942zacwenn@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

May 25, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-05-25.