NCT06600932

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

September 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 15, 2024

Last Update Submit

September 15, 2024

Conditions

Cataract Surgery Experience

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (1)

  • Visual field

    From enrollment to the end of treatment at 2 weeks

Other Outcomes (1)

  • Visual quality

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

TMS

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Procedure: control group

Interventions

TMSPROCEDURE

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.

TMS
control groupPROCEDURE

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.

Control

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye and Ear, Nose Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Xiangjia Zhu

    Eye and ENT Hospital of Fudan University

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangjia Zhu

CONTACT

0086+02164377134zhuxiangjia1982@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(1)