CClinicalTrials.gg
Not yet recruitingNCT06600932Updated Sep 19, 2024

Evaluation of TMS Visual Outcome

An interventional study of TMS and control group in Cataract Surgery Experience, sponsored by Shanghai High Myopia Study Group. Not yet recruiting at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Shanghai High Myopia Study Group · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Cataract Surgery Experience

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's planned enrollment of 200 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Shanghai High Myopia Study Group is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • Sham comparator
    Control

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

    Procedure: control group

Interventions

  • ProcedureTMS

    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.

  • Procedurecontrol 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.

06

What researchers measure

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

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

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

07

Study locations

1 site
  • Eye and Ear, Nose Throat Hospital of Fudan University
    Shanghai, Shanghai 200031, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06600932
Lead sponsor
Shanghai High Myopia Study Group
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Xiangjia Zhu
Contact
zhuxiangjia1982@126.com
0086+02164377134
Xiangjia Zhu
study chair · Eye and ENT Hospital of Fudan University
Jiaqi Meng
principal investigator · Eye and ENT Hospital of Fudan University
Yinglei Zhang
principal investigator · Eye and ENT Hospital of Fudan University
Yating Tang
principal investigator · Eye and ENT Hospital of Fudan University
Xin Liu
principal investigator · Eye and ENT Hospital of Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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