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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hyperbaric oxygen therapy can protect nerves in individuals with optic neuropathy, a condition where damage to the optic nerve affects vision. Participants will receive either actual hyperbaric oxygen therapy or a sham version (a placebo treatment) for 20 days. This design allows researchers to compare the effects of the treatment against no treatment. The trial suits individuals diagnosed with optic neuropathy who can commit to the study's schedule. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatments for optic neuropathy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally safe for most people. In various studies, participants have tolerated it well, with few serious side effects. Some research has examined HBOT for eye problems, such as optic neuropathy. These studies suggest that HBOT might help with vision issues, but success is not guaranteed.

The treatment involves breathing pure oxygen in a pressurized room or chamber. This method is already approved for other conditions, like decompression sickness, indicating its safety. Side effects are usually minor and can include ear pressure discomfort or temporary changes in vision.

Overall, while there are no major safety concerns, the effectiveness for optic neuropathy specifically remains under study. Those interested should consult a healthcare provider to make an informed decision about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperbaric oxygen therapy for optic neuropathy because it offers a unique approach compared to traditional treatments, which often involve corticosteroids or surgery. Unlike these standard methods, hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized room or chamber, which can enhance oxygen delivery to damaged optic nerves, potentially promoting healing and restoring vision. This method has the potential to provide faster and more direct improvement in vision by addressing the underlying issue of oxygen deficiency that contributes to optic nerve damage. Additionally, the use of a sham hyperbaric oxygen arm in trials helps ensure the true effectiveness of the therapy is accurately measured, adding to the excitement and anticipation of new findings in the treatment landscape for optic neuropathy.

What evidence suggests that hyperbaric oxygen therapy might be an effective treatment for optic neuropathy?

This trial will compare Hyperbaric Oxygen Therapy (HBOT) with Sham Hyperbaric Oxygen to evaluate their effects on optic neuropathy. Research has shown mixed results for HBOT in treating optic neuropathy, which involves damage to the optic nerve. Some studies suggest that early use of HBOT might aid in acute retinal artery occlusion, a serious eye condition, and lead to good vision recovery. However, other studies found no significant vision improvement for patients with nonarteritic anterior ischemic optic neuropathy, another type of optic nerve damage. Animal studies suggest that HBOT might protect the optic nerve, but these results have not been confirmed in humans. Overall, while HBOT has potential, its effectiveness for optic neuropathy in humans remains uncertain. ^{5 6 7 8 9}

Who Is on the Research Team?

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10779579/

Hyperbaric Oxygen Therapy in Ophthalmology: A Narrative ... Early HBOT intervention seems beneficial for ARAO, potentially resulting in good visual recovery. A recent study published in Undersea and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002939414721142

Hyperbaric Oxygen Therapy for Nonarteritic Anterior ... Hyperbaric oxygen therapy using 100% oxygen and 2.0 absolute atmospheres of pressure did not produce a significant improvement in visual acuity or visual field.

3. stanfordhealthcare.org stanfordhealthcare.org/trials/manual/a_randomized_control_858328632.html

A Randomized, Controlled, Masked Phase II Study to ... The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment of patients with optic neuropathy.

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2011.00023/full

Neuroprotective Effect of Hyperbaric Oxygen Therapy on ... The study investigated the therapeutic effect of hyperbaric oxygen (HBO) on anterior ischemic optic neuropathy in a rodent model (rAION).

5. withpower.com withpower.com/trial/phase-optic-nerve-diseases-10-2022-447aa

Hyperbaric Oxygen Therapy for Optic Neuropathy In a study involving 20 patients with acute nonarteritic anterior ischemic optic neuropathy, hyperbaric oxygen therapy did not significantly improve visual ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16625263/

Hyperbaric oxygen therapy for radiation-induced optic ... Conclusions: There is still no consistently successful treatment for RON. HBO may be attempted in selected cases, but the prognosis for preservation of vision ...

7. mdpi.com mdpi.com/2077-0383/13/1/29

Hyperbaric Oxygen Therapy in Ophthalmology: A Narrative ... This paper provides an overview of the theoretical effectiveness and most recent indications for HBOT in ophthalmology.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11009234/

Ocular effects of hyperbaric oxygen therapy - PubMed Central While HBOT shows promise in improving visual outcomes for acute post-surgical or post-traumatic optic neuropathy, its efficacy in treating eye ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939414721142

Hyperbaric Oxygen Therapy for Nonarteritic Anterior ... Hyperbaric oxygen therapy using 100% oxygen and 2.0 absolute atmospheres of pressure did not produce a significant improvement in visual acuity or visual field.