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Hyperbaric Oxygen Therapy for Optic Neuropathy (HBOT Trial)

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be at least 18 years old

Participant with clinical evidence of optic neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 6 months

Awards & highlights

HBOT Trial Summary

This trial tests if hyperbaric oxygen therapy can help protect vision in people with optic neuropathy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Hyperbaric oxygen therapy may cause ear pressure, temporary nearsightedness, lung collapse due to air pressure changes, and rarely, oxygen poisoning which could lead to seizures.

HBOT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with optic neuropathy.

HBOT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Field- Mean Deviation

Change in Visual Field- Visual Field Index

Secondary outcome measures

Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography

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

HBOT Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric Oxygen

2005

Completed Phase 3

~260

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,290 Total Patients Enrolled

Jeffrey L Goldberg, MD PhDStudy ChairStanford University

2 Previous Clinical Trials

65 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies open in this research project for participants?

"Affirmative. According to clinicaltrials.gov, this research project is actively seeking participants since its original posting on November 1st 2022 and most recent update on November 7th 2023. Sixty patients are required for the trial at a single medical centre."

Answered by AI

What is the current enrolment size for this clinical trial?

"Affirmative. An inspection of clinicaltrials.gov reveals that this research initiative, which was first advertised on November 1st 2022, is actively seeking participants at the present time. 60 patients need to be recruited from a solitary medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperbaric Oxygen Therapy for Optic Neuropathies

Jeffrey L Goldberg 2022. "Hyperbaric Oxygen Therapy for Optic Neuropathies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128720.

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