Recruiting NCT06128720

Hyperbaric Oxygen Therapy for Optic Neuropathies

No phase Interventional Optic Neuropathy Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Hyperbaric Oxygen, Sham Hyperbaric Oxygen.
Who it may be relevant to: Registry conditions: Optic Neuropathy, Glaucoma. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Device Hyperbaric Oxygen
Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen
Device Sham Hyperbaric Oxygen
Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air.

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]

Secondary outcome measures (2)

Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography [Time frame: Baseline through 6 months]
Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography [Time frame: Baseline through 6 months]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT06128720 · 59547