Evaluation of TMS Visual Outcome

Not Applicable

Not yet recruiting

• Conditions: Cataract Surgery Experience
• Interventions: Procedure: TMS; Procedure: control group

• Registration Number: NCT06600932
• Lead Sponsor: Shanghai High Myopia Study Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-15
• Last Update Submitted: 2024-09-15
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS	TMS	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.
Control	control group	The sham group will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.

Primary Outcome Measures

Name	Time	Method
Visual acuity	From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Name	Time	Method
Visual field	From enrollment to the end of treatment at 2 weeks

Trial Locations

Locations (1)

Eye and Ear, Nose Throat Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China