Health TrialsbyHealthPanel

Hyperbaric Oxygen Therapy for Optic Neuropathies

ConditionsOptic NeuropathyGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric Oxygen

    Device

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

  • Sham Hyperbaric Oxygen

    Device

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Open LabelExperimental treatment 1 intervention
Group B: Active Hyperbaric OxygenExperimental treatment 1 intervention
Group C: Sham Hyperbaric OxygenPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Visual Field- Mean Deviation

Humphrey visual field testing with standard MD output

Time frame
Baseline through 6 months
2

Change in Visual Field- Visual Field Index

Humphrey visual field testing with standard VFI output

Time frame
Baseline through 6 months

Secondary outcomes

1

Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography

OCT testing with standard GCC output

Time frame
Baseline through 6 months
2

Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography

OCT testing with standard RNFL output

Time frame
Baseline through 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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