Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in … (NCT07700147) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration
South Korea40 participantsStarted 2026-07-09
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration.
The main questions this study aims to answer are:
* Does the investigational device improve visual function, as assessed by best corrected visual acuity and contrast sensitivity?
* What treatment-emergent adverse events occur during the study?
Participants will:
* Be randomized to receive either active stimulation or sham stimulation
* Apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period
* Visit the study site for eye examinations and safety assessments
* Return for a follow-up visit 4 weeks after the end of treatment
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants aged 50 years or older
. Participants diagnosed with early or intermediate dry age-related macular degeneration
. Participants with best corrected visual acuity measured by the ETDRS visual acuity chart of 20/200 or better and 20/30 or worse
. Participants who have voluntarily decided to participate in the study and have provided written informed consent.
Exclusion criteria
. Participants with atrophy involving the foveal center with a diameter of 175 micrometers or greater in at least one eye, as observed by fundus examination or fundus autofluorescence imaging
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
. Participants with exudative age-related macular degeneration in at least one eye, as observed by fundus examination or optical coherence tomography (OCT)
. Participants with a history of intraocular injection therapy or macular laser treatment, including focal laser photocoagulation or photodynamic therapy
. Participants with retinal or choroidal diseases other than early or intermediate age-related macular degeneration that may affect the study results, including diabetic retinopathy, retinal artery occlusion, retinal vein occlusion, central serous chorioretinopathy, optic neuritis, or uveitis
. Participants who have undergone vitrectomy due to retinal disease, or cataract surgery within 1 month prior to screening
. Participants with ocular media opacity or other conditions that, in the investigator's opinion, may make ophthalmic imaging difficult to interpret, including cataract, vitreous opacity, or vitreous hemorrhage
. Participants with uncontrolled chronic systemic diseases, including diabetes mellitus or chronic kidney disease, or a history of malignancy, except for cases with no recurrence within the past 5 years and no history of chemotherapy
. Participants with autoimmune diseases, including Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or Graves' disease