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Systemic oxygen therapy versus oral enalapril for treatment of diabetic macular ischemia: a randomized controlled trial

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Abstract

The purpose of this study was to evaluate the structural and functional effects of systemic oxygen therapy and enalapril in patients with diabetic macular ischemia (DMI). This randomized clinical trial consisted of 105 eyes with DMI divided into three groups. Group I received systemic oxygen by face mask at a flow rate of 10 L/min; Group II received 5 mg enalapril daily; and Group III received placebo tablets for 3 months. Best-corrected visual acuity (BCVA), central macular thickness (CMT) measured by optical coherence tomography (OCT), extent of foveal avascular zone (FAZ) on fluorescein angiograms, and electroretinograms (ERG) were obtained at baseline and after 3 and 6 months. Overall, 102 patients completed the study. Baseline characteristics were not significantly different among groups. Significant improvement in BCVA and decrease in CMT and FAZ occurred at months 3 and 6 in oxygen group compared to deterioration in enalapril and control groups (All P values <0.001). ERG parameters were significantly better in oxygen group compared to enalapril group at months 3 and 6 and better than those in control group at month 3. Normobaric oxygen therapy for 3 months in DMI decreased CMT and FAZ and improved BCVA and ERG parameters. Enalapril did not show any favorable effect.

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Acknowledgements

This study was financially supported by Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

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Authors and Affiliations

  1. Department of Ophthalmology and Ophthalmic Research Center, Labbafinejad Medical Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Pasdaran Ave. Boostan 9 St., 16666, Tehran, Iran

    Farideh Sharifipour, Alireza Ramezani, Mohsen Azarmina, Roham Soheilian & Masoud Soheilian

  2. Department of Ophthalmology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Farideh Sharifipour

  3. Negah Eye Hospital, Tehran, Iran

    Mohammadreza Razzaghi, Alireza Ramezani, Mohsen Azarmina & Masoud Soheilian

  4. Imam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Alireza Ramezani

  5. Department of Epidemiology and Biostatistics, Tehran University of Medical Sciences, Tehran, Iran

    Mehdi Yaseri

Authors
  1. Farideh Sharifipour
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  2. Mohammadreza Razzaghi
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  3. Alireza Ramezani
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  4. Mohsen Azarmina
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  5. Mehdi Yaseri
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  6. Roham Soheilian
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  7. Masoud Soheilian
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Corresponding author

Correspondence to Masoud Soheilian.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in this study were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

Trial registration: clinical trials.gov identifier: NCT00899587

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Sharifipour, F., Razzaghi, M., Ramezani, A. et al. Systemic oxygen therapy versus oral enalapril for treatment of diabetic macular ischemia: a randomized controlled trial. Int Ophthalmol 36, 225–235 (2016). https://doi.org/10.1007/s10792-015-0123-1

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  • DOI: https://doi.org/10.1007/s10792-015-0123-1

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