TES-GPS Study Protocol
Cross-source consensus on TES-GPS Study Protocol from 1 sources and 7 claims.
1 sources · 7 claims
Dosage & preparation
Risks & contraindications
Comparisons
Background
Highlighted claims
- TES-GPS is a prospective, randomised, double-masked, sham-controlled, monocentric pilot study with a parallel-group design. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol
- The trial plans to enroll 50 patients randomised 1:1 to active TES or sham stimulation. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol
- Each participant's study duration is 18 months with up to 13 scheduled visits. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol
- The study is funded by the German Federal Ministry of Education and Research. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol
- Sham participants receive a brief subthreshold current for only 30 seconds followed by 0 microamps to preserve masking. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol
- The study follows ISO 14155, EU Medical Device Regulation 2017/745, ICH GCP, and the Declaration of Helsinki. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol
- Some study team members must remain unmasked to determine phosphene and tolerance thresholds and to program the device. — Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol