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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00899587
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Ischemia Drug: enalapril Other: oxygen Drug: placebo Phase 1

Study Type: Interventional
Official Title: Evaluation of the Effects of Oxygen Therapy and Enalapril for Diabetic Macular Ischemia

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Arms Assigned Interventions
Experimental: Oxygen Other: 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
Experimental: Enalapril Drug: enalapril
enalapril 5 mg every night
Placebo Comparator: Control Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899587


Contacts
Contact: Masoud Soheilian, MD +982122585952 labbafi@hotmail.com

Locations
Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of, 166666
Contact: Masoud Soheilian, MD    +98 21 22585952    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

ClinicalTrials.gov Identifier: NCT00899587     History of Changes
Other Study ID Numbers: 8753
First Submitted: May 11, 2009
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Ischemia
Pathologic Processes
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents