Oxygen Therapy for Retinal Ischemia

Retinal Ischemia Clinical Trial

Official title:

Normobaric Nocturnal Hyperoxia Therapy for Treating Ischemic-Related Retinal Conditions

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03730779
• Other study ID #: Trials2018
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 30, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will be using nocturnal normobaric hyperoxia therapy in patients with diagnoses of conditions related to retinal ischemia.

Description:

Patients who receive a diagnosis of a condition relate to retinal ischemia and who pass the eligibility criteria will receive an oxygen concentrator to use at home. They will report back in follow up monthly for three to six months.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of retinal-ischemia related condition

Exclusion Criteria:

• Complicating other ocular condition

• History of smoking or lung conditions

Related Conditions & MeSH terms

• Ischemia
• Retinal Ischemia

Intervention

Drug:
• Hyperoxia
Patients will receive nocturnal normobaric hyperoxia therapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity	Best Corrected Visual Acuity as measured by ETDRS chart	6 months
Primary	Macula Edema	Amount of ME present, as measured by OCT	6 months