Hyperbaric Oxygen Therapy for Optic Neuropathy
(HBOT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Corneal opacification, Pregnancy, Drug abuse, others
Trial Summary
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.
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.
12345Is 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.
36789How 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.
123510Eligibility 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
I am 18 years old or older.
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.
+1 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open LabelExperimental Treatment1 Intervention
Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial.
Group II: Active Hyperbaric OxygenExperimental Treatment1 Intervention
Participants will get Hyperbaric oxygen therapy for 20 days.
Group III: Sham Hyperbaric OxygenPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Byers Eye InstitutePalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Hyperbaric oxygen therapy for nonarteritic anterior ischemic optic neuropathy. [2022]To evaluate the effectiveness of hyperbaric oxygen therapy in reducing optic nerve damage in acute nonarteritic anterior ischemic optic neuropathy.
Hyperbaric oxygen therapy of olfactory dysfunction in diabetic neuropathy with type 2 diabetes mellitus and a new definition Diabetic Olfactopathy. [2022]Hyperbaric Oxygen therapy is recommended as an adjuvant therapy for diabetic neuropathy. To investigate olfactory dysfunction and show the effectiveness of hyperbaric oxygen treatment in patients with type 2 diabetic neuropathy.
Hyperbaric oxygen therapy for radiation-induced optic neuropathy. [2020]Radiation-induced optic neuropathy (RON) is an infrequent but devastating consequence of radiation exposure to the visual pathways, usually following months to years after the treatment of paranasal or intracranial tumours. Hyperbaric oxygen (HBO) therapy is one of several therapies that have been tried for this condition. The purpose of this review is to describe the clinical characteristics of RON, the rationale for the use of HBO in this condition, and the available clinical data on its safety and efficacy.
Case report: hyperbaric oxygen and MRI findings in radiation-induced optic neuropathy. [2014]Hyperbaric oxygen (HBO2) therapy has been utilized in conjunction with systemic corticosteroid administration for treating radiation-induced optic neuropathy (RON) with varying success. We present the case of a 78-year-old female with RON who received two courses of HBO2 (without corticosteroids) and also pre- and post-treatment magnetic resonance imaging (MRI) of her brain. Her visual acuity subjectively and functionally improved throughout her first course of 30 treatments, including regaining the ability to ambulate independently, but subsequently deteriorated following completion. A second course of 40 additional treatments was prescribed; the patient's visual symptoms subjectively improved once more, followed again with subsequent decline after treatment. Post-treatment MRI also showed resolution of previously visible optic nerve contrast enhancement. This patient represents the 27th reported case of RON treated with HBO2 and the first reported case of radiologic and transient symptomatic improvement without concomitant steroid use. Our case adds additional evidence to the limited anecdotal data supporting MRI correlation with RON symptoms and HBO2 in RON treatment as well.
Visual recovery from radiation-induced optic neuropathy. The role of hyperbaric oxygen therapy. [2006]Optic neuropathy resulting in permanent visual loss is an infrequent delayed complication of radiation therapy. Hyperbaric oxygen therapy (HBO) has been used to treat such a complication, but its efficacy is controversial. We report a patient who presented with radiation-induced optic neuropathy 17 months after irradiation for a left maxillary antrum melanoma. HBO fully reversed visual loss in the more recently involved eye, and slightly improved vision in the earlier affected eye.
Adverse effects of hyperbaric oxygen therapy: a systematic review and meta-analysis. [2023]Hyperbaric oxygen therapy (HBOT) is one of the common clinical treatments, but adverse effects have hampered and limited the clinical application and promotion of hyperbaric oxygen therapy. A systematic review and meta-analysis of the adverse effects of hyperbaric oxygen therapy have conducted by our group to provide a theoretical basis for clinical treatment.
A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]To describe the distribution and occurrence of adverse events recorded during hyperbaric oxygen (HBO) therapy from 2012 to 2015. In this analysis, events are defined as otic/sinus barotrauma, confinement anxiety, hypoglycemia, oxygen toxicity, pneumothorax, seizure, and shortness of breath.
The safety of hyperbaric oxygen treatment--retrospective analysis in 2,334 patients. [2016]Hyperbaric oxygen (HBO2) therapy is applied in a growing number of cases for patients with different comorbidities and is considered a generally safe therapy. The main side effects related to HBO2 therapy are barotrauma, central nervous system- and pulmonary oxygen toxicity, claustrophobia, anxiety and visual disturbances. The aim of this study was to evaluate the incidence of side effects associated with HBO2 therapy and risk factors in a large cohort of patients treated for different indications.
Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]Hyperbaric oxygen (HBO2) therapy is a safe and well-tolerated treatment modality. Seizures, one of the most severe central nervous system side effects of HBO2 therapy, can occur. Episodes of seizures during HBO2 therapy have not yet been reported in countries such as Korea, where hyperbaric medicine is still in the developmental stage.
The effects of hyperbaric oxygen on visual functions in ischaemic optic neuropathy. [2016]The effects of hyperbaric oxygen therapy were studied in nine patients with non-arteritic anterior ischaemic optic neuropathy, who had been unsatisfactorily treated with corticosteroids. In four patients with signs of optic disc atrophy there was no improvement of visual functions after hyperbaric oxygen treatment, whereas in the other five patients, who had no signs of optic disc atrophy, visual acuity and visual field improved. The achieved improvements were maintained at a control examination six months later. Results suggest that hyperbaric oxygen might be a new remedy for the selected cases of non-arteritic ischaemic optic neuropathy and call for a controlled clinical study aiming to accurately assess its efficacy.