Accommodation-Related Visual Training Combined with Transcranial Electrical Stimulation Versus Visual Training Alone for the Treatment of Accommodation Dysfunction
A Single-center, Prospective, Randomized Controlled Trial Evaluating Accommodation-related Visual Training Combined with Transcranial Electrical Stimulation Versus Accommodation-related Visual Training Alone for the Treatment of Accommodation Dysfunction
1 other identifier
interventional
100
1 country
1
Brief Summary
This is a single-center, randomized controlled trial to compare the effectiveness of transcranial electrical stimulation combined with visual training with visual training alone for the treatment of accommodation disorder patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedStudy Start
First participant enrolled
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 5, 2024
December 1, 2024
8 months
December 2, 2024
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Amplitude of Accommodation
using minus lens method to evaluate amplitude of accommodation
Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Accommodation Response
using binocular cross-cylinder method to evaluate accommodation response
Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Positive and negative relative accommodation
using phoropter examination to evaluate positive and negative relative accommodation
Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Accommodation Facility
Using flipper to evaluate the accommodation facility
Before treatment, 1 week, 1 month, 3 months, 6 months after treatment
Study Arms (2)
Transcranial Electrical Stimulation Group
EXPERIMENTALvisual training combined with transcranial electrical stimulation
Visual Training Group
ACTIVE COMPARATORvisual training
Interventions
Transcranial Electrical Stimulation Combined with Accommodation-related Visual Training
Eligibility Criteria
You may not qualify if:
- no history of other eye diseases or eye surgeries
- no history of neuropsychiatric diseases for the individual or relatives
- no head injuries or surgeries
- no history of epilepsy or stroke
- no metal implants in the body
- no claustrophobia, no metal implants in the body (fracture fixation nails, pacemakers, etc.)
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye & ENT Hospital of Fudan University
Shanghai, China, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wen Wen, MD, PhD
Eye & ENT Hospital of Fudan University, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2024
First Posted
December 4, 2024
Study Start
December 31, 2024
Primary Completion
August 30, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
December 5, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
We concerns about patient privacy issues and it iss better to protect the publication potential.