Correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of Prostaglandin E1 (PGE1) (Alprostadil), expected to improve visual function in patients with ischemic optic neuropathy previous non-arteritic (NOIANA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Intravenous infusion of PGE1 (Days 0, +1 and +2)
Intravenous infusion of physiological saline solution
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
RECRUITINGdetermination of visual acuity
Test ETDRS (Early Treatment Diabetic Retinopathy Study)
Time frame: Change from baseline visual acuity at 90 days.
Number of Serious Adverse Events
Adverse Event
Time frame: Day 1, day +4,day+30 , day +90.
Intraocular Pressure
Intraocular Pressure
Time frame: Day1,day+30 , day +90.
Visual Field
Humphrey Field Analyzer (HFA),
Time frame: Day1,day+30 , day +90.
Thickness of the layer of nerve fibers and ganglion cells in the retina
Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:
Time frame: Day1,day+30 , day +90.
fundoscopic evaluation
Biomicroscopy
Time frame: Day1,day+30 , day +90.
Hemodynamic indices of the ocular arteries
Doppler SIEMENS Antares™ System:
Time frame: Day1,day+30 , day +90.
Optical disc area and cup / disc
Cirrus , Carl Zeiss Meditec, Dublin, California, ver: 6.0.2.81:
Time frame: Day1,day+30 , day +90.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.