Hyperbaric Oxygen Therapy for Optic Neuropathies (HBOT)

Stanford University

Status: Enrolling

Conditions: Glaucoma; Optic Neuropathy

Treatments: Device: Sham Hyperbaric Oxygen; Device: Hyperbaric Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT06128720

59547

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Open Label

Experimental group

Description:

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

Treatment:

Device: Hyperbaric Oxygen

Active Hyperbaric Oxygen

Experimental group

Description:

Participants will get Hyperbaric oxygen therapy for 20 days.

Treatment:

Device: Hyperbaric Oxygen

Sham Hyperbaric Oxygen

Placebo Comparator group

Description:

Participants will get a Sham Hyperbaric oxygen therapy for 20 days

Treatment:

Device: Sham Hyperbaric Oxygen