Non-Arteritic Anterior Ischemic Optic Neuropathy Clinical Trial
Official title:
Visual Field Defects in Non-Arteritic Anterior Ischemic Optic Neuropathy: Effect of Vision Restoration Therapy (VRT)
The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects.
Anterior ischemic optic neuropathy (AION) is one of the most common causes of optic
neuropathy after the age of 50. There is currently no available treatment and although up to
40% of patients have some spontaneous improvement within the first few months, most patients
remain visually devastated. About 50% of patients retain relatively spared central visual
acuity with an inferior altitudinal visual field defect. These patients usually complain of
difficulty reading and loss of depth perception.
Recently, training-induced enlargement of visual field defects has been demonstrated in some
patients with VF defects secondary to lesions of the retrochiasmal visual pathways. This
computer-based Vision Restoration Therapy (VRT) was developed in Germany and has been
FDA-cleared in the United States for the past one year.
VRT is currently available at Emory for patients with homonymous hemianopia. Patients work
on personally-designed software (on a laptop at home) twice daily (30 minutes each) for 6
months. Zones of partially damaged neurons, which are usually located between the intact and
damaged area of the visual field (transition zone) are deliberately stimulated by VRT. There
is only anecdotal evidence that this visual restoration therapy may be helpful in enlarging
the visual field of patients with optic neuropathies.
The goal of this pilot study is to evaluate the effect of VRT on the visual function of
patients with unilateral or bilateral AION, who have good central vision (at least 20/60)
and altitudinal visual field defects. The effect of VRT will be evaluated by visual acuity,
color vision, stereo vision, Humphrey VF (24-2 SITA standard) testing, and scales evaluating
reading speed and vision-based quality of life. These measures will be repeated before VRT,
at 3 months, at 6 months, and at 1 year after VRT. 20 patients will be included in the
study. Patients will be randomized at inclusion between VRT and sham (placebo)-training (10
in each group). The 10 patients receiving sham training will then receive VRT for the
following 6 months if they so choose. All data will be analyzed in a blinded fashion. The
company developing VRT in the United States (NOVAVISION) has agreed to provide VRT and
sham-training.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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