Cataract Surgery ExperienceNCT06600932
Evaluation of TMS Visual Outcome
A study testing TMS in people with Cataract Surgery Experience, run by Shanghai High Myopia Study Group at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cataract Surgery Experience
- What is being tested?
- TMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post cataract surgery
- Best-corrected visual acuity less than 0.1logMAR
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Eye and Ear, Nose Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Xiangjia Zhu, 0086+02164377134, zhuxiangjia1982@126.com
About this study
Official title: 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.
- Conditions
- Cataract Surgery Experience
- Being tested
- TMS, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSProcedure or surgery
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 groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: TMS |
| Control | Sham comparator | The sham group will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation. Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (1)
Visual field
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract Surgery ExperienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai High Myopia Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangjia Zhu, Study chair, Eye & ENT Hospital of Fudan UniversityJiaqi Meng, Principal investigator, Eye & ENT Hospital of Fudan UniversityYinglei Zhang, Principal investigator, Eye & ENT Hospital of Fudan UniversityYating Tang, Principal investigator, Eye & ENT Hospital of Fudan UniversityXin Liu, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600932
- Sponsor's protocol ID
- HMSG2024015
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Magnetic Stimulation on Visual Outcome in Patients After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06600932
- Acronym / sponsor ID
- HMSG2024015
- Conditions
- Cataract Surgery Experience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai High Myopia Study GroupUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Procedure: TMSTMS 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. |
| Control | Sham comparator | Procedure: control groupThe sham group will be exposed to the recorded sounds of TMS pulses but without real magnetic stimulation. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post cataract surgery
- Best-corrected visual acuity less than 0.1logMAR
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSTMS 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. | Procedure or surgery | TMS |
| control groupThe 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. | Procedure or surgery | Control |
Primary outcome
Visual acuity
Time frame: From enrollment to the end of treatment at 2 weeks
1 secondary outcome
Visual field
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangjia Zhu study chair
Eye & ENT Hospital of Fudan University
Jiaqi Meng principal investigator
Eye & ENT Hospital of Fudan University
Yinglei Zhang principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Cataract Surgery Experience, run by Shanghai High Myopia Study Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangjia Zhu (0086+02164377134, zhuxiangjia1982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.