Retinal Degeneration, Vision Impairment and Blindness
Conditions
Brief summary
The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) works to restore vision in adults with severe retinal degeneration. It will also learn about the safety of TMS treatment. The main questions it aims to answer are: 1. Does TMS treatment improve the visual function of participants? 2. What medical problems do participants have when receiving TMS treatment? Researchers will compare TMS treatment to a sham stimulation (identical procedures using a sham coil without effective magnetic field output) to see if TMS treatment works to restore their vision. Participants will: UndergoTMS treatment to a sham stimulation for consecutive 5 days Visit the clinic at 5 days, 4 weeks, 3 months, 6 months, 12 months after start of the treatment for checkups and tests
Interventions
PROCEDURETranscranial magnetic stimulation targeting occipital visual cortex
Transcranial magnetic stimulation targeting occipital visual cortex
PROCEDURESham stimulation
identical procedure using a sham coil without effective magnetic field output
Sponsors
Shanghai High Myopia Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* between 45 and 70 years old * bilateral severe MMD (META-PM grades ≥ 3) * no prior TMS history or contraindications to TMS
Exclusion criteria
* other significant ocular diseases, such as refractive media opacity, glaucoma, uveitis, ocular trauma, untreated retinal detachment, or lens dislocation * received anti-vascular endothelial growth factor treatment or other ocular surgeries within 3 months * history of epilepsy or family history of epilepsy, intracranial metal implants, or severe cerebrovascular diseases * mental illness, cognitive impairment (MMSE score \< 24), unable to communicate effectively * severe heart disease, liver or kidney dysfunction, or coagulation disorders * pregnant or lactating women * currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity (BCVA) change | Baseline and 3 months | the change of best-corrected visual acuity (BCVA, measured by internationally standard EDTRS chart) between 3 months after the end of treatment and baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected visual acuity (BCVA) change | Baseline and 12 months | the change of BCVA (EDTRS) between 12 months after treatment and baseline |
Countries
China
Contacts
CONTACTXiangjia Zhu, PhD, MD
CONTACTJiaqi Meng, MD
PRINCIPAL_INVESTIGATORXiangjia Zhu, PhD, MD
Eye and Ear, Nose, Throat Hospital of Fudan University
PRINCIPAL_INVESTIGATORMingguang He
The Hong Kong Polytechnic University
PRINCIPAL_INVESTIGATORRong Wu
Huadong Hospital of Fudan University
PRINCIPAL_INVESTIGATORBo Ma
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Outcome results
None listed