Evaluation of TMS Visual Outcome

September 15, 2024 updated by: Shanghai High Myopia Study Group

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Eye and Ear, Nose Throat Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Sham Comparator: Control
The sham group will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual field
Time Frame: From enrollment to the end of treatment at 2 weeks
From enrollment to the end of treatment at 2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai High Myopia Study Group

Investigators

  • Study Chair: Xiangjia Zhu, Eye and ENT Hospital of Fudan University
  • Principal Investigator: Jiaqi Meng, Eye and ENT Hospital of Fudan University
  • Principal Investigator: Yinglei Zhang, Eye and ENT Hospital of Fudan University
  • Principal Investigator: Yating Tang, Eye and ENT Hospital of Fudan University
  • Principal Investigator: Xin Liu, Eye and ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMSG2024015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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