NCT07107646

Brief Summary

This exploratory study investigates whether perceptual learning using blurred Gabor stimuli can improve uncorrected distance visual acuity in children aged 6-10 years with low myopia. Participants will be randomly assigned to a training group or control group. The training group will undergo individualized visual perceptual learning through a digital Vision Training System (VTS) for approximately 3 months. The study will also evaluate changes in refraction, contrast sensitivity, visual crowding, Chinese reading acuity with eye movements, and sweep visual evoked potentials (sVEPs).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Aug 2025Jul 2027

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

November 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

July 30, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Low MyopiaPerceptual LearningVisual AcuityVisual Evoked Potentials

Outcome Measures

Primary Outcomes (1)

  • Change in Best Corrected Visual Acuity (BCVA) From Baseline

    Best Corrected Visual Acuity (BCVA) will be measured using the ETDRS or Snellen chart at a distance of 3 meters under standardized lighting conditions. The change in BCVA from baseline to post-training will be assessed.

    From enrollment to 12 months after completion of the 3-month training program

Secondary Outcomes (5)

  • Change in Spherical Equivalent Refraction (Diopters) From Baseline

    From enrollment to 12 months after completion of the 3-month training program

  • Change in Contrast Sensitivity Across Spatial Frequencies From Baseline

    From enrollment to 12 months after completion of the 3-month training program

  • Change in Visual Crowding Acuity From Baseline

    From enrollment to 12 months after completion of the 3-month training program

  • Change in Reading Visual Acuity and Eye Movement Parameters From Baseline

    From enrollment to 12 months after completion of the 3-month training program

  • Change in Visual Acuity Measured by Sweep Visual Evoked Potentials (sVEP) From Baseline

    From enrollment to 12 months after completion of the 3-month training program

Study Arms (2)

Visual Perceptual Learning Group

EXPERIMENTAL

Children aged 6-10 years with low myopia will receive a structured visual perceptual learning (VPL) intervention using computerized blurred Gabor discrimination tasks. Training will be conducted at least twice per week, with each session lasting approximately 15-30 minutes, for up to 3 months. Training parameters will be remotely monitored and adjusted based on individual progress. Participants will undergo baseline, post-training, and follow-up assessments of uncorrected visual acuity, refractive error, contrast sensitivity, visual crowding, Chinese reading visual acuity, eye movement performance, and sweep visual evoked potentials (sVEP).

Behavioral: vision training system, VTS

Control Group

NO INTERVENTION

Children aged 6-10 years with low myopia who meet the same inclusion and exclusion criteria will not receive the VPL training during the study period. They will undergo the same schedule of baseline, post-study, and follow-up assessments as the experimental group, including evaluations of uncorrected visual acuity, refractive error, contrast sensitivity, visual crowding, Chinese reading visual acuity, eye movement performance, and sweep visual evoked potentials (sVEP).

Interventions

Participants in this group will receive individualized visual perceptual learning using the Vision Training System (VTS). The training involves blurred Gabor stimuli presented via a computer-based application. Each participant will complete approximately 20 training sessions over 3 months, with each session lasting 15 to 30 minutes, conducted twice per week. The program is designed to enhance uncorrected visual acuity, contrast sensitivity, and other visual functions by engaging neural mechanisms related to perceptual learning. Training progression is adaptive based on individual performance. The VTS software was developed in collaboration with Bar Ilan University.

Visual Perceptual Learning Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 6 to 10 years.
  • Best corrected distance visual acuity of 6/6 or 0.00 logMAR.
  • Diagnosed with low myopia after a comprehensive ophthalmologic examination, with a spherical equivalent refractive error ranging from -0.50 to -1.25 diopters, including up to -0.75 diopters of astigmatism.
  • Not currently undergoing any of the four standard myopia control treatments for children:
  • Atropine (mydriatic agent)
  • Orthokeratology
  • Peripheral defocus soft contact lenses
  • Peripheral defocus spectacle lenses (frame glasses)
  • Willing and able to provide informed consent, and able to comply with study procedures and assessments.

You may not qualify if:

  • Participants will be excluded if they have any of the following ophthalmologic conditions:
  • Strabismus
  • Binocular vision problems
  • Ocular diseases
  • History of ocular surgery (excluding refractive surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Occupational Therapy, College of Medicine, National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Myopia

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Inspiratory CapacityVital CapacityTotal Lung CapacityLung Volume MeasurementsRespiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

November 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations