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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00899587
Other study ID # 8753
Secondary ID
Status Recruiting
Phase Phase 1
First received May 11, 2009
Last updated May 11, 2009

Study information

Verified date May 2009
Source hahid Beheshti University of Medical Sciences
Contact Masoud Soheilian, MD
Phone +982122585952
Email labbafi@hotmail.com
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Drug:
enalapril
enalapril 5 mg every night
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
Drug:
placebo


Locations

Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of,