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The Effectiveness of Visual Training in Convergence Insufficiency Patients

Primary Purpose

Convergence Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Visual training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Convergence Insufficiency focused on measuring Visual training, Prism, Binocular vision

Eligibility Criteria

9 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The overall score of CI symptom survey ≥ 16 (9-18 years old) or ≥ 21 (19-30 years old) The break point of near point of convergence (NPC) ≥ 6 cm Exophoria at near distances be at least 4∆ higher than at far distances Near positive fusional vergence (PFV) ≤ 15∆ or failing Sheard's criterion at near. Exclusion Criteria: The best corrected visual acuity (BCVA) of < 20/25 in each eye at far and near distances Amblyopia patients or the difference of BCVA between the two eyes ≥ 2 lines Constant strabismus patients History of strabismus surgery or refractive surgery Systemic diseases that would affect binocular vision Acquired brain injury or neurological disorder.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stop training group

Continune training group

Arm Description

Home-base prism training during week 1-6 --> then stop training during week 7-12 --> endpoint data collected at week 12

Home-base prism training during week 1-12 --> endpoint data collected at week 12

Outcomes

Primary Outcome Measures

Binocular vision and visual function evaluation
Change from baseline best corrected visual acuity: distance visual acuity measured for each eye at a distance of 6 m and at near 40 cm for each eye will be measured using Snellen charts. NPC and the amplitude of accommodation will be measured using Royal Air Force (RAF) rule. Stereoacuity will be measured by the Random dot stereotest.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2022
Last Updated
March 6, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05603962
Brief Title
The Effectiveness of Visual Training in Convergence Insufficiency Patients
Official Title
The Effectiveness of Visual Training Using Prisms on Visual Symptoms and Binocular Vision in Convergence Insufficiency Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Convergence insufficiency (CI) is one of the most common binocular vision disorders. The prevalence of CI ranges from 3% to 6% in school-aged children. CI symptoms include visual fatigue, headache, blurred vision, and diplopia and could be caused while using near-distance viewing. These symptoms might become more severe with increasing need to perform near-distance tasks. Long-term visual symptoms could result in a negative impact on learning behaviors and work performance in patients. Nowadays, visual training is the main type of management for CI patients clinically; however, the existing training protocol required patients to make several visits to the clinic for visual training, which might increase the burden for patients and result in higher failures in training. Therefore, this study will use a simple training method by utilizing prisms for CI patients to train at home, then compare visual symptoms and binocular vision after the training. In stage I of this study, investigators will recruit 60 symptomatic CI participants aged 9 to 30 years old to do a 6-week visual training with the prisms (15 min/time, 3 times/week). The post-training outcomes will be collected at week 4 and week 6. In stage II, all of the participants will be randomly divided into the "stop training group" and the "continue training group." The participants in the "continue training group" will have the same 6-week prism training and in the "stop training group" will stop all the prism training during this period. The final post-training outcomes of all the participants will be collected again at week 12. In this study, investigators will investigate the effectiveness of the prisms training for 6 weeks and for 12 weeks on visual symptoms and binocular vision in CI patients, and evaluate whether the training effect will be affected by stopping training after 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convergence Insufficiency
Keywords
Visual training, Prism, Binocular vision

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stop training group
Arm Type
Active Comparator
Arm Description
Home-base prism training during week 1-6 --> then stop training during week 7-12 --> endpoint data collected at week 12
Arm Title
Continune training group
Arm Type
Experimental
Arm Description
Home-base prism training during week 1-12 --> endpoint data collected at week 12
Intervention Type
Behavioral
Intervention Name(s)
Visual training
Intervention Description
Visual training is the main type of management for CI patients clinically; however, the existing training protocol required patients to make several visits to the clinic for visual training, which might increase the burden for patients and result in higher failures in training. Therefore, this study will use a simple training method by utilizing prisms for CI patients to train at home, then compare visual symptoms and binocular vision after the training.
Primary Outcome Measure Information:
Title
Binocular vision and visual function evaluation
Description
Change from baseline best corrected visual acuity: distance visual acuity measured for each eye at a distance of 6 m and at near 40 cm for each eye will be measured using Snellen charts. NPC and the amplitude of accommodation will be measured using Royal Air Force (RAF) rule. Stereoacuity will be measured by the Random dot stereotest.
Time Frame
12 weeks for each participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The overall score of CI symptom survey ≥ 16 (9-18 years old) or ≥ 21 (19-30 years old) The break point of near point of convergence (NPC) ≥ 6 cm Exophoria at near distances be at least 4∆ higher than at far distances Near positive fusional vergence (PFV) ≤ 15∆ or failing Sheard's criterion at near. Exclusion Criteria: The best corrected visual acuity (BCVA) of < 20/25 in each eye at far and near distances Amblyopia patients or the difference of BCVA between the two eyes ≥ 2 lines Constant strabismus patients History of strabismus surgery or refractive surgery Systemic diseases that would affect binocular vision Acquired brain injury or neurological disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu-Hsun Tsai, PhD
Phone
886223123456
Ext
265906
Email
lucia_tsai@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu-Hsun Tsai, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei county
ZIP/Postal Code
100225
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzu-Hsun Tsai, PhD
Phone
886223123456
Ext
265906
Email
lucia_tsai@yahoo.com.tw

12. IPD Sharing Statement

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The Effectiveness of Visual Training in Convergence Insufficiency Patients

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