Glaucoma is a progressive optic neuropathy with retinal ganglion cell loss which leads to visual field loss. Open-angle glaucoma is the most common form of glaucoma. The aim of this pilot study is to evaluate the safety and effectiveness of the treatment of visual field defects using transcorneal electrical stimulation (TES) with the OkuStim 2 System in patients with primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma.
Electrical stimulation therapy with the OkuStim System can help patients with retinitis pigmentosa and other hereditary retinal diseases slow the progression of visual field defects and thus preserve usable vision for longer. Since degenerative processes in the retina also lead to loss of vision in patients with glaucoma, the desired clinical benefit in this group of patients is also to slow down the decline in the visual field. This is a prospective, single-center, randomized, sham-controlled, double-masked pilot study in a parallel group design. Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES with maximum tolerated current intensity below the pain threshold (tolerance threshold). Patients are stimulated in one eye (study eye). Since these are patients with progressive visual field defects and the experimental therapy is being compared with a sham treatment, the patients also receive pressure-lowering eye drops ("treatment as usual", "TAU") to ensure the safety of the study participant. Treatment duration is 18 months for each patient, with application of TES once a week for 30min.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Retinal stimulation is achieved through transcorneal current application: using a thread electrode, a weak current (≤ 1mA) is introduced onto the surface of the eye, which spreads through the eye towards the retina.
Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
Mainz, Germany
RECRUITINGDifference in Humphrey visual field examination between the TES-treated group and the sham-treated group
Time frame: 18 months
Visual field - Changes in the average in the Mean Deviation
Time frame: 6/12/18 months
Visual field - Changes in local visual field defects in at least 3 positions
Time frame: 18 months
Visual acuity
Visual acuity measurements will be done using the 4 meter Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.
Time frame: 18 months
Intraocular pressure
Time frame: 18 months
OCT
GCL-OCT (macular cube), thickness
Time frame: 18 months
OCT
OCT optic nerve (RNFL), thickness
Time frame: 18 months
Flavoprotein fluorescence
Flavoprotein fluorescence (FPF) will be measured with the OcuMet Beacon. FPF will be reported both by intensity (a cumulative value reflecting global signal strength), and heterogeneity (measures variation of the relative intensity across the image).
Time frame: 18 months
NEI-VFQ-25
Original numeric values from the survey are converted to a 0 to 100 scale (scores represent the achieved percentage of the total possible score). To calculate an overall composite score for the VFQ-25, the vision-targeted subscale scores are averaged.
Time frame: 18 months
Additional antiglaucoma therapies
Comparison between groups regarding additional antiglaucomatous therapies (nature and number of e.g. eye drops, surgery, laser treatments)
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.