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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00899587
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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 Medical University:

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00899587     History of Changes
Other Study ID Numbers: 8753
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014