Evaluation of TMS Visual Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract Surgery Experience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

TMS

Intervention Type PROCEDURE

TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual 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

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

Group Type SHAM_COMPARATOR

control group

Intervention Type PROCEDURE

The control treatment is a sham-controlled procedure, in which participants will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.

Interventions

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TMS

TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual 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.

Intervention Type PROCEDURE

control group

The control treatment is a sham-controlled procedure, in which participants will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR