RecruitingNot ApplicableNCT06128720

Hyperbaric Oxygen Therapy for Optic Neuropathies

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

Sponsor

Stanford University

Enrollment

60 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Glaucoma Optic Neuropathy

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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.

Interventions

DEVICEHyperbaric Oxygen

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

DEVICESham Hyperbaric Oxygen

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

Locations(1)

Byers Eye Institute

Palo Alto, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06128720

Related Trials

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT043545451 location

Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma

NCT066829621 location