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New treatment option for Glaucoma
Official title Transcorneal Electrical Stimulation for the Treatment of Visual Field Defects in Patients With Open-Angle Glaucoma
ClinicalTrials.gov ID: NCT06682962
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Willingness to participate in the study, the people signed and dated informed consent must be submitted before the start of the screening
- Age ≥ 40 years
- Primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma (according to the EGS criteria) in...
- Current progression in perimetry of at least 1.5 dB per year in the study eye and mean defect (MD) in the study eye between ≥ 6 and ≤ 12 dB (Octopus...
- Visual acuity ≥ 0.2 decimal in the study eye (corresponds to a visual acuity of 0.7 logMAR)
You likely can't join if
- , the eye with the higher MD is selected as the study eye. If the MD is the same in both eyes, the eye with the worse visual acuity will be selected...
- Negative serum or urine pregnancy test at screening in women of childbearing potential. Participants are considered to be of nonchildbearing...
- Women of childbearing potential must agree to be abstinent or to use highly effective methods of contraception that result in a failure rate of less...
- Neovascularisations of any origin in the study eye
- Condition after arterial or venous occlusions in the study eye
- Condition after intraocular surgery in the last 3 months before the screening examination in the study eye
See the full eligibility criteria
- Willingness to participate in the study, the people signed and dated informed consent must be submitted before the start of the screening
- Age ≥ 40 years
- Primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma (according to the EGS criteria) in the study eye
- Current progression in perimetry of at least 1.5 dB per year in the study eye and mean defect (MD) in the study eye between ≥ 6 and ≤ 12 dB (Octopus visual field) or ≤ -6 and ≥ -12 dB (Humphrey visual field) in the...
- Visual acuity ≥ 0.2 decimal in the study eye (corresponds to a visual acuity of 0.7 logMAR)
- The patient must master home stimulation after extensive training.
- Ability of subject to understand the scope, significance and individual consequences of participation in the study
- Ability of subject to give consent
- If both eyes meet the inclusion/
- , the eye with the higher MD is selected as the study eye. If the MD is the same in both eyes, the eye with the worse visual acuity will be selected as the study eye. If there is no difference between the eyes, the...
- Negative serum or urine pregnancy test at screening in women of childbearing potential. Participants are considered to be of nonchildbearing potential if they are postmenopausal and have not menstruated for at least 12...
- Women of childbearing potential must agree to be abstinent or to use highly effective methods of contraception that result in a failure rate of less than 1% per year. This applies consistently throughout the duration of...
- Neovascularisations of any origin in the study eye
- Condition after arterial or venous occlusions in the study eye
- Condition after intraocular surgery in the last 3 months before the screening examination in the study eye
- Acute (intra)ocular inflammation in any eye
- Non-proliferative or proliferative diabetic retinopathy in the study eye
- Condition after retinal detachment in the study eye
- Dry age-related macular degeneration affecting the visual field in the study eye
- Exsudative age-related macular degeneration in the study eye
- Macular edema of any origin in the study eye
- Other relevant retinal diseases in the study eye
- Any form of corneal degeneration that limits vision in the study eye
- Any disease other than glaucoma affecting the central 30° visual field in the study eye
- No cataract surgery or other eye surgery may be planned for the patient in the study eye during the duration of the study (except laser trabeculoplasty)
- Patients with active implants
- General illnesses that are difficult to control/adjust and which, in the opinion of the investigator, could jeopardize regular study routines
- Poor general condition according to the investigators assessment
- Mental illness or dementia, that, in the opinion of the investigator, reduces the understanding of the study procedures and use of the Okustim 2 System
- Simultaneous participation in another treatment study or past interventions whose effect may still be ongoing (30 days)
- Breastfeeding women
- Patients unable to consent
- Previous enrolment in the TES-GPS study
- Contraindications to the use of OkuStim 2 such as allergies/hypersensitivity to silver
The study team makes the final eligibility decision.
Where it's taking place
- Mainz, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mainz, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.