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Active, Not Recruiting

NCT Number: NCT05626491

Electrical Stimulation for the Treatment of Glaucoma

The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otto-von-Guericke University, Magdeburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must be at least 18.
  • Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
  • Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false positives do not exceed 20%.
  • Visual Field Index between 10 and 90%
  • Corrected visual acuity ≥ 1.00 (logMAR), 20/200 (Snellen), 0.10 (decimal)
  • In the opinion of the investigator the participant's eye pressure must be clinically stable.
  • If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
  • Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

Exclusion criteria

  • Participant is unable to comply with study procedures or follow-up visits.
  • Participant has a history of ocular herpes zoster.
  • Participant has pathological nystagmus
  • Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
  • Participant has evidence of corneal opacification or lack of optical clarity.
  • Participant has uveitis or other ocular inflammatory disease.
  • Participant has any electric or electronic implants such as a pacemaker.
  • Participant has acute conjunctivitis.
  • Participant has acute autoimmune disease.
  • Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
  • Participant is pregnant or lactating.
  • Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. Including but not limited to all forms of dementia.
  • Unresected brain tumors
  • Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable
  • Patients with any skin damage.
  • Children and comatose patients.
  • Patients with history of epileptic seizure within the last 10 years.
  • Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
  • Self-reported alcohol or illicit drug addictions within the last 12 months.
  • Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation
  • Prior participation in a vision training/stimulation study in the last 12 months

Treatment and study plan

Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Device

Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina

Other names: Electrical Stimulation

Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Device

Patients receive sham treatment (no active stimulation) every other day via a headband.

Primary outcomes

  1. Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).

    Time frame: Baseline through 6 months

Secondary outcomes

  1. Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).

    Time frame: Baseline through 6 months

  2. Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.

    Time frame: Baseline through 6 months

    Pelli-Robson is a standard for measuring contrast sensitivity. It is measured on a 0-16 scale. Normal contrast sensitivity is between 12 and 14 with 0 being worst and 16 being best.

  3. Change from baseline in visual acuity as assessed by the Snellen visual acuity test.

    Time frame: Baseline through Month 6

    The Snellen test is a standard eye chart test used to test eyesight.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • NYU Langone Health
  • Otto-von-Guericke University Magdeburg
  • Wills Eye

Registry information

Official study title

Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma

Acronym: rtACS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 23, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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