Clinical Trials/NCT03730779

NCT03730779

Withdrawn

Phase 4

Normobaric Nocturnal Hyperoxia Therapy for Treating Ischemic-Related Retinal Conditions

Beth Israel Deaconess Medical Center1 site in 1 countryNovember 30, 2018

ConditionsRetinal Ischemia

InterventionsHyperoxia

DrugsHyperoxia

Overview

Phase: Phase 4
Intervention: Hyperoxia
Conditions: Retinal Ischemia
Sponsor: Beth Israel Deaconess Medical Center
Locations: 1
Primary Endpoint: Macula Edema
Status: Withdrawn
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

November 30, 2018

End Date

January 1, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beth Israel Deaconess Medical Center

Responsible Party

Principal Investigator

Jorge Arroyo

Associate Professor of Ophthalmology

Beth Israel Deaconess Medical Center

Eligibility Criteria

Inclusion Criteria

•Diagnosis of retinal-ischemia related condition

Exclusion Criteria

•Complicating other ocular condition
•History of smoking or lung conditions

Arms & Interventions

O2 recieving

Patients who receive hyperoxia

Intervention: Hyperoxia

Outcomes

Primary Outcomes

Macula Edema

Time Frame: 6 months

Amount of ME present, as measured by OCT

Best Corrected Visual Acuity

Time Frame: 6 months

Best Corrected Visual Acuity as measured by ETDRS chart

Study Sites (1)

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