Electrical Stimulation for Lazy Eye

Overseen By Avrey Thau

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wills Eye

Disqualifiers: Retinal degeneration, Pregnancy, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OkuStim® to determine if it can improve vision in adults with amblyopia, commonly known as "lazy eye." Participants will receive either the real treatment with the OkuStim® device or a sham (inactive) treatment, each lasting 30 minutes once a week for 12 weeks. Researchers aim to discover if the real treatment is more effective than the sham in improving vision. Individuals diagnosed with amblyopia and vision in the affected eye of 20/70 or worse might be suitable for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research in vision improvement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that transcorneal electrical stimulation (TES) is safe for improving visual function in adults with amblyopia?

Research has shown that the OkuStim® device, used for transcorneal electrical stimulation (TES), is very safe. Studies have found that TES is well-tolerated over many years, with no serious safety issues reported. In a small study involving patients with retinitis pigmentosa (a type of eye disease), TES proved safe and did not cause any serious problems.

The most common side effect was mild, temporary dry eye. Over many years of clinical use, TES has demonstrated a strong safety profile. Based on past research, TES with OkuStim® is generally considered safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for amblyopia, like patching or atropine drops, focus on forcing the weaker eye to work harder by covering the stronger eye or blurring it with drops. However, OkuStim® is unique because it uses transcorneal electrical stimulation to directly target the visual system. This method involves applying mild electrical pulses to the eye, which can potentially enhance visual function by stimulating the retina and improving neural pathways. Researchers are excited about OkuStim® because it offers a non-invasive alternative that could work more directly on the visual system, potentially leading to improved outcomes for patients with amblyopia.

What evidence suggests that transcorneal electrical stimulation is effective for improving visual function in amblyopia?

Research has shown that using the OkuStim® device for transcorneal electrical stimulation (TES) might improve vision in people with amblyopia, also known as "lazy eye." TES sends small electrical signals to the eye, stimulating weak or damaged cells that aid vision. In previous studies, 95% of patients reported satisfaction with TES therapy, suggesting its effectiveness. Additionally, no major side effects have been found in TES users, indicating it may be a safe option. Participants in this trial will be assigned to either the OkuStim® group, receiving active TES, or the Sham-OkuStim® group, where the device will not be activated. While more research is needed, these findings are promising for TES as a treatment. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Diagnosis of amblyopia made by the principal investigators.

Best corrected visual acuity in the amblyopic eye equal to or worse than 20/70

Willing and able to give informed consent and to participate for the full duration of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcorneal electrical stimulation (TES) or sham treatment for 12 weeks

12 weeks

12 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OkuStim®
• Sham-OkuStim®

How Is the Trial Designed?

Group I: OkuStim® Experimental Treatment 1 Intervention

The OkuStim® group will undergo 30-minute treatments once a week for 12 weeks at 200% threshold level according to their individual phosphene threshold (IPT) readings from the OkuStim® device at the pre-treatment visit (week 1). Rectangular biphasic current pulses (1-ms positive, directly followed by 1-ms negative) will be applied at a frequency of 20 Hz.

Group II: Sham-OkuStim® Placebo Group 1 Intervention

Subjects in the Sham-OkuStim® group will wear treatment glasses and corneal electrodes for 30 minutes weekly for 12 weeks, but corneal electrodes will not be activated.

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials

81

Recruited

15,400+

Harold P. Koller, MD

Collaborator

Trials

1

Recruited

40+

Judith B. Lavrich, MD

Collaborator

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10390189/

Outcomes of transcorneal electrical stimulation therapy in the ... Twenty of the patients (95.24%) stated that they were satisfied with the TES therapy. No considerable side effect was observed in any patient due to the therapy ...

2. okuvision.de okuvision.de/en/clinical-studies/

Clinical Studies A recent exploratory analysis of the data collected in 2014 now provides further evidence of the effectiveness of OkuStim therapy. The data show that after one ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02019927

Electric Stimulation of the Eye to Improve Vision After Trauma Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5751865/

Transcorneal electrical stimulation for the treatment of retinitis ... Visual function measurements at 6 months demonstrated no significant difference between the control and treated eyes. The results justify a ...

5. karger.com karger.com/ore/article/63/3/234/258908/Transcorneal-Electrical-Stimulation-for-the

Transcorneal Electrical Stimulation for the Treatment of ... The primary outcome measure was the safety profile following 6 months of weekly treatment. No serious adverse events (SAEs) relating to the ...

6. retinauk.org.uk retinauk.org.uk/wp-content/uploads/2021/04/Okuvision_Application_and_Effect_of_TcES.pdf

OkuStim The safety of TcES therapy with the OkuStim System has been demonstrated in over 140 years of application in clinical trials without serious adverse events. Fig ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06682962

Transcorneal Electrical Stimulation for the Treatment of ... 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) ...

8. researchgate.net researchgate.net/publication/337604557_Transcorneal_Electrical_Stimulation_for_the_Treatment_of_Retinitis_Pigmentosa_A_Multicenter_Safety_Study_of_the_OkuStimR_System_TESOLA-Study

Transcorneal Electrical Stimulation for the Treatment of ... Conclusion: The present results confirm the excellent safety profile of TES. Transient dry eye symptoms were the most common adverse event.