NCT06682962

Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma

Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma - a Monocentric, Randomized, Double-Masked, Sham-Controlled Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Okuvision GmbH · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glaucoma
• Primary Open Angle Glaucoma
• Pseudoexfoliation Glaucoma
• Pigment Dispersion Glaucoma
• Normal Tension Glaucoma

Interventions

Type	Name	Description
DEVICE	Transcorneal electrical stimulation (TES) with the OkuStim 2 System	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.

Timeline

• Start date: 2025-04-02
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-11-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: Germany