Clincosm LogoSign in Get a demo

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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00899587
Collaborator
(none)
1
Location
3
Arms

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Research Center Tehran Iran, Islamic Republic of 166666

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00899587
    Other Study ID Numbers:
    • 8753
    First Posted:
    May 12, 2009
    Last Update Posted:
    May 12, 2009
    Last Verified:
    May 1, 2009
    Additional relevant MeSH terms:
    Ischemia
    Enalapril

    Study Results

    No Results Posted as of May 12, 2009