Evaluation of TMS Visual Outcome

Shanghai High Myopia Study Group

Status: Not yet enrolling

Conditions: Cataract Surgery Experience

Treatments: Procedure: TMS; Procedure: control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06600932

HMSG2024015

Details and patient eligibility

About

The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients after cataract surgery. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients after cataract surgery? Researchers will compare TMS to the sham-controlled treatment (exposure to recorded sounds of pulses without real magnetic stimulation) to see if TMS works to improve the visual outcomes of patients after cataract surgery.

Participants will

• Undergo TMS treatment or a sham-controlled treatment for consecutive 5 days.
• Visit the clinic once every 2 weeks for checkups and tests.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post cataract surgery
• Best-corrected visual acuity less than 0.1logMAR

Exclusion criteria

• Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
• Diagnosed with significant opacity of refractive media that affects observation of visual function;
• History of epileptic seizures;
• Long term use of psychotropic drugs；
• Metal implants in the body.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

TMS

Experimental group

Description:

TMS treatment indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.

Treatment:

Procedure: TMS

Control

Sham Comparator group

Description:

The sham group will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.

Treatment:

Procedure: control group