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NCT Number: NCT06600932

Evaluation of TMS Visual Outcome

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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Key information

Conditions

Cataract Surgery Experience

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and Ear, Nose Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location contact

Xiangjia Zhu

CONTACT

[email protected]

0086+02164377134

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMS

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 Group

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.

Primary outcomes

  1. Visual acuity

    Time frame: From enrollment to the end of treatment at 2 weeks

Secondary outcomes

  1. Visual field

    Time frame: From enrollment to the end of treatment at 2 weeks

Other outcomes

  1. Visual quality

    Time frame: From enrollment to the end of treatment at 12 weeks

    Include objective visual quality (contrast sensitivity) and subjective visual quality (visual function questionnaire score).

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangjia Zhu

CONTACT

[email protected]

0086+02164377134

Sponsors and collaborators

Lead sponsor

Shanghai High Myopia Study Group

Other

Registry information

Official study title

Effects of Transcranial Magnetic Stimulation on Visual Outcome in Patients After Cataract Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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