Hyperbaric Oxygen Therapy for Optic Neuropathy

(HBOT Trial)

Overseen By Zac Wennberg Smith

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Corneal opacification, Pregnancy, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently participating in another clinical trial or have done so in the last 3 months, you may not be eligible.

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Optic Neuropathy?

Research shows that Hyperbaric Oxygen Therapy (HBOT) has been used with some success in treating optic neuropathy caused by radiation, with cases reporting improvements in vision and MRI findings. Additionally, HBOT is recommended as an additional therapy for diabetic neuropathy, suggesting it may help with nerve-related conditions. ^{1 2 3 4 5}

Is hyperbaric oxygen therapy safe for humans?

Hyperbaric oxygen therapy is generally considered safe, but it can have side effects like ear or sinus pain (barotrauma), anxiety in small spaces (claustrophobia), and in rare cases, seizures. These side effects have been observed in various conditions, not just optic neuropathy. ^{3 6 7 8 9}

How is hyperbaric oxygen therapy different from other treatments for optic neuropathy?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized room, which can help improve blood flow and oxygen delivery to damaged optic nerves. This approach is different from standard treatments like corticosteroids, as it directly enhances oxygen supply to the affected area, potentially aiding recovery in certain cases of optic neuropathy. ^{1 2 3 5 10}

What is the purpose of this trial?

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

Research Team

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 with optic neuropathy, who can follow the study's schedule and understand/sign the consent form. It's not suitable for those unable to meet these requirements or participate fully.

Inclusion Criteria

Participant must have the ability to comply with the requirements of the study and complete the schedule of events (SOE)

I have been diagnosed with 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Hyperbaric oxygen therapy or Sham therapy for 20 days

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Hyperbaric Oxygen
• Sham Hyperbaric Oxygen

Trial Overview The study tests hyperbaric oxygen therapy's ability to protect nerve cells in the eye from damage caused by optic neuropathy. Participants will either receive real or sham (fake) treatments to compare effectiveness.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

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

Group II: Active Hyperbaric Oxygen Experimental Treatment 1 Intervention

Participants will get Hyperbaric oxygen therapy for 20 days.

Group III: Sham Hyperbaric Oxygen Placebo Group 1 Intervention

Participants will get a Sham Hyperbaric oxygen therapy for 20 days

Hyperbaric Oxygen is already approved in United States, European Union for the following indications:

Approved in United States as HBOT for:

• Air or Gas Embolism
• Carbon Monoxide Poisoning
• Central Retinal Artery Occlusion
• Decompression Sickness
• Gas Gangrene
• Idiopathic Sudden Sensorineural Hearing Loss
• Progressive Necrotizing Soft Tissue Infections

Approved in European Union as HBOT for:

• Air or Gas Embolism
• Carbon Monoxide Poisoning
• Central Retinal Artery Occlusion
• Decompression Sickness
• Gas Gangrene
• Idiopathic Sudden Sensorineural Hearing Loss
• Progressive Necrotizing Soft Tissue Infections

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

In a study involving 20 patients with acute nonarteritic anterior ischemic optic neuropathy, hyperbaric oxygen therapy did not significantly improve visual acuity or visual field sensitivity compared to untreated controls.

The treatment, which consisted of two 90-minute sessions of 100% oxygen at 2.0 absolute atmospheres over ten days, showed no significant benefits regardless of the timing of therapy after symptom onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for nonarteritic anterior ischemic optic neuropathy. Arnold, AC., Hepler, RS., Lieber, M., et al.[2022]

Hyperbaric Oxygen (HBO) therapy significantly improves olfactory function in patients with type 2 diabetic neuropathy, as shown by statistically significant differences in olfactory test scores before and after treatment.

This study is the first to demonstrate that HBO therapy can effectively address olfactory dysfunction in diabetic patients, highlighting its potential as an adjuvant treatment for diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy of olfactory dysfunction in diabetic neuropathy with type 2 diabetes mellitus and a new definition Diabetic Olfactopathy. Veyseller, B., Dogan, R., Yenigun, A., et al.[2022]

Radiation-induced optic neuropathy (RON) is a serious condition that can occur after radiation treatment for tumors, and it typically presents with rapid vision loss and specific clinical symptoms.

Hyperbaric oxygen (HBO) therapy may be considered for RON, but it must be started soon after vision loss begins, and even then, its effectiveness is variable, with no consistently successful treatments currently available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for radiation-induced optic neuropathy. Levy, RL., Miller, NR.[2020]

A 78-year-old female with radiation-induced optic neuropathy (RON) showed subjective and functional improvement in visual acuity after two courses of hyperbaric oxygen (HBO2) therapy, despite not using corticosteroids, which is a common treatment approach.

Post-treatment MRI scans indicated resolution of optic nerve contrast enhancement, suggesting a potential correlation between MRI findings and symptomatic improvement in RON, adding to the limited evidence supporting HBO2 therapy for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: hyperbaric oxygen and MRI findings in radiation-induced optic neuropathy. Li, CQ., Gerson, S., Snyder, B.[2014]

A case study of a patient with radiation-induced optic neuropathy showed that hyperbaric oxygen therapy (HBO) can effectively reverse visual loss, particularly in the eye affected more recently after radiation treatment.

HBO also provided slight improvement in vision for the eye that was affected earlier, suggesting potential benefits of this therapy for patients experiencing delayed complications from radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual recovery from radiation-induced optic neuropathy. The role of hyperbaric oxygen therapy. Borruat, FX., Schatz, NJ., Glaser, JS., et al.[2006]

Hyperbaric oxygen therapy (HBOT) is associated with a higher incidence of adverse effects (30.11%) compared to control groups (10.43%), particularly when the treatment involves more than 10 sessions or chamber pressures exceed 2.0 ATA.

The most common side effect reported was ear discomfort, indicating that while HBOT can be beneficial, careful monitoring for adverse reactions is necessary, especially under specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. Zhang, Y., Zhou, Y., Jia, Y., et al.[2023]

In a review of over 1.5 million hyperbaric oxygen therapy treatments, only 0.68% were linked to adverse events, indicating that serious complications are rare.

The most common issues reported were barotrauma and confinement anxiety, while severe events like oxygen toxicity occurred in less than 0.05 per 1000 treatments, suggesting that HBO therapy is a safe and low-risk treatment when following proper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. Jokinen-Gordon, H., Barry, RC., Watson, B., et al.[2022]

In a study of 2,334 patients undergoing hyperbaric oxygen (HBO2) therapy, 17.4% experienced adverse events, with the most common being middle ear barotrauma affecting 9.2% of patients.

Despite some side effects, the overall incidence of complications was low at 0.72% per session, indicating that with proper protocols and monitoring, HBO2 therapy is a safe treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. hadanny, A., Meir, O., Bechor, Y., et al.[2016]

In a study of 1,308 patients receiving hyperbaric oxygen (HBO2) therapy, five seizure episodes were reported during 10,425 treatments, indicating a low but notable risk of seizures, particularly in patients with carbon monoxide poisoning and arterial gas embolism.

Despite the occurrence of seizures, none of the patients experienced lasting effects, suggesting that while seizures can happen during HBO2 therapy, the overall safety profile remains high, and clinicians should be prepared to manage such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. Lee, CH., Choi, JG., Lee, JS., et al.[2021]

In a study of nine patients with non-arteritic anterior ischaemic optic neuropathy who did not respond well to corticosteroids, hyperbaric oxygen therapy showed improvement in visual functions for five patients without optic disc atrophy.

The improvements in visual acuity and visual field were sustained for at least six months, suggesting that hyperbaric oxygen therapy could be a promising treatment option for certain cases of this condition, warranting further controlled clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of hyperbaric oxygen on visual functions in ischaemic optic neuropathy. Bojić, L., Kovacević, H., Andrić, D., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for nonarteritic anterior ischemic optic neuropathy. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy of olfactory dysfunction in diabetic neuropathy with type 2 diabetes mellitus and a new definition Diabetic Olfactopathy. [2022]

3. Singapore pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for radiation-induced optic neuropathy. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Case report: hyperbaric oxygen and MRI findings in radiation-induced optic neuropathy. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Visual recovery from radiation-induced optic neuropathy. The role of hyperbaric oxygen therapy. [2006]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]

10. Croatia pubmed.ncbi.nlm.nih.gov

The effects of hyperbaric oxygen on visual functions in ischaemic optic neuropathy. [2016]