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

Primary Purpose

Diabetic Macular Ischemia

Status

Unknown status

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

enalapril

oxygen

placebo

About this trial

This is an interventional trial for Diabetic Macular Ischemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxygen

Enalapril

Control

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00899587

First Posted

May 11, 2009

Last Updated

May 11, 2009

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00899587

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Ischemia

7. Study Design

Study Phase

Phase 1

8. Arms, Groups, and Interventions

Arm Title

Oxygen

Arm Type

Experimental

Arm Title

Enalapril

Arm Type

Experimental

Arm Title

Control

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

enalapril

Intervention Description

enalapril 5 mg every night

Intervention Type

Other

Intervention Name(s)

oxygen

Intervention Description

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

Drug

Intervention Name(s)

placebo

10. Eligibility

Sex

All

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Masoud Soheilian, MD

Phone

+982122585952

labbafi@hotmail.com

Facility Information:

Facility Name

Ophthalmic Research Center

City

Tehran

ZIP/Postal Code

166666

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Masoud Soheilian, MD

Phone

+98 21 22585952

labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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