Hyperbaric Oxygen Therapy for Optic Neuropathies

Glaucoma Clinical Trial

— HBOT  

Official title:

A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128720
• Other study ID #: 59547
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Zac Wennberg Smith
• Phone: 6504975942
• Email: zacwenn[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Optic Nerve Diseases
• Optic Neuropathy

Intervention

Device:
• Hyperbaric Oxygen
Participant will undergo 60 minutes of Hyperbaric oxygen at 1.5ATA while breathing 100% oxygen
• Sham Hyperbaric Oxygen
Participant will undergo 60 minutes of Sham Hyperbaric Oxygen at atmospheric pressure while breathing room air.

Locations

Country	Name	City	State
United States	Byers Eye Institute	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Field- Mean Deviation	Humphrey visual field testing with standard MD output	Baseline through 6 months
Primary	Change in Visual Field- Visual Field Index	Humphrey visual field testing with standard VFI output	Baseline through 6 months
Secondary	Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography	OCT testing with standard GCC output	Baseline through 6 months
Secondary	Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography	OCT testing with standard RNFL output	Baseline through 6 months