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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether hyperbaric oxygen therapy—breathing oxygen under higher pressure—can protect the nerve that carries signals from the eye to the brain. It is for adults with optic neuropathy, a condition that damages this nerve.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Have signs of damage to the nerve that carries signals from the eye to the brain.
  • Be able to follow study rules and complete all planned visits and activities.
  • Understand and sign the consent form. If poor vision prevents you from reading it, the whole form will be read to you.
  • Meet all entry rules at both the screening visit and the starting visit, unless noted otherwise.

Who can't join

  • Cannot follow study steps or attend follow-up visits.
  • Have clouding of the clear front of the eye or other loss of clarity inside the eye.
  • Are in another drug study now, or were in one in the past 3 months, involving a drug given to the study eye or the whole body.
  • Are pregnant or breastfeeding.
  • Have a physical or mental condition that the study doctor thinks could make joining unsafe or affect study tests or results.
  • Are under 18, in a coma, or misusing drugs or alcohol.
  • Had hyperbaric oxygen treatment in the past 6 months.
  • Have a fear of closed spaces or cannot adjust properly when pressure is lowered.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA