Glaucoma, Normal Tension Glaucoma, Pigment Dispersion Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Conditions
Keywords
TES, TcES, POAG, OkuStim, Okuvision, Glaucoma, Electrical Stimulation
Brief 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.
Interventions
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.
Sponsors
Okuvision GmbH
Interdisciplinary Center for Clinical Trials, University Medical Center Mainz
University Medical Center of the Johannes Gutenberg University Mainz, Department of Ophthalmology
Sponsored by the German Federal Ministry of Education and Research (FKZ 13GW0732A)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patient is masked to the treatment group he or she has been assigned to. The determination of the tolerance threshold and the programming of the stimulation parameters on the OkuStim 2 is carried out by unmasked members of the study team as it is impossible to program the OkuStim 2 without knowing the assignment of the patient to the study group. Examinations relating to the primary, secondary or exploratory endpoints are carried out only by masked team members.
Intervention model description
Patients are assigned 1:1 to one of two different groups: Sham group (sham treatment) or TES group.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willingness to participate in the study, the subjects signed and dated informed consent must be submitted before the start of the screening 2. Age ≥ 40 years 3. Primary open-angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or normal tension glaucoma (according to the EGS criteria) in the study eye 4. 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 screening examination as the mean value of the two visual field examinations carried out as part of the screening (permitted deviation maximum 2 dB) 5. Visual acuity ≥ 0.2 decimal in the study eye (corresponds to a visual acuity of 0.7 logMAR) 6. The patient must master home stimulation after extensive training. 7. Ability of subject to understand the scope, significance and individual consequences of participation in the study 8. Ability of subject to give consent 9. If both eyes meet the inclusion/
Exclusion criteria
, 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 right eye will be selected as the study eye 10. 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 months prior to screening or if they are surgically sterile 11. 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 the treatment once you have given your consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Humphrey visual field examination between the TES-treated group and the sham-treated group | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual field - Changes in the average in the Mean Deviation | 6/12/18 months | — |
| Visual field - Changes in local visual field defects in at least 3 positions | 18 months | — |
| Visual acuity | 18 months | Visual acuity measurements will be done using the 4 meter Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. |
| Intraocular pressure | 18 months | — |
| OCT | 18 months | GCL-OCT (macular cube), thickness |
| Flavoprotein fluorescence | 18 months | 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). |
| NEI-VFQ-25 | 18 months | 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. |
| Additional antiglaucoma therapies | 18 months | Comparison between groups regarding additional antiglaucomatous therapies (nature and number of e.g. eye drops, surgery, laser treatments) |
Countries
Germany
Contacts
CONTACTKatrin Lorenz, Prof.
PRINCIPAL_INVESTIGATORKatrin Lorenz, Prof.
Augenklinik und Poliklinik der Universitätsmedizin Mainz, Johannes Gutenberg-Universität Mainz
Outcome results
None listed