Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

NCT ID: NCT00899587

Last Updated: 2009-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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In this study, patients were divided into 3 group with 35 cases including: 1.oxygen 2.enalapril 3.control.

In the beginning of the study, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and optical coherence tomography (OCT) were measured. Patients in the oxygen group were given oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month. In the enalapril group, patients were given enalapril 5 mg every night and placebo was given for the patients in third group. At the end of first month the patients' vision was checked again and at the the end of the third month the first physical examinations were performed. In the first group, arterial blood gas (ABG) was taken before and after oxygen therapy as well.

Detailed Description

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Conditions

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Diabetic Macular Ischemia

Study Groups

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Oxygen

Group Type EXPERIMENTAL

oxygen

Intervention Type OTHER

oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month

Enalapril

Group Type EXPERIMENTAL

enalapril

Intervention Type DRUG

enalapril 5 mg every night

Control

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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enalapril

enalapril 5 mg every night

Intervention Type DRUG

oxygen

oxygen 10 lit/min 1 hour twice a day at the first month, once a day at the second month and every other day at the third month

Intervention Type OTHER

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with diabetic macular ischemia

Exclusion Criteria

* HTN \> 1140/90 or HTN controlled by ACE inhibitors
* FBS \> 200
* Severe anemia, COPD, cataract, HRPDR and diffuse macular edema
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Masoud Soheilian, MD

Role: CONTACT

+982122585952

Facility Contacts

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Masoud Soheilian, MD

Role: primary

+98 21 22585952

Other Identifiers

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8753

Identifier Type: -

Identifier Source: org_study_id

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