Skip to content

The Effectiveness of Visual Training in Convergence Insufficiency Patients

The Effectiveness of Visual Training Using Prisms on Visual Symptoms and Binocular Vision in Convergence Insufficiency Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05603962
Enrollment
12
Registered
2022-11-03
Start date
2023-03-06
Completion date
2024-06-26
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Convergence Insufficiency

Keywords

Visual training, Prism, Binocular vision

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.

Interventions

BEHAVIORALVisual training

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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

1. The overall score of CI symptom survey ≥ 16 (9-18 years old) or ≥ 21 (19-30 years old) 2. The break point of near point of convergence (NPC) ≥ 6 cm 3. Exophoria at near distances be at least 4∆ higher than at far distances 4. Near positive fusional vergence (PFV) ≤ 15∆ or failing Sheard's criterion at near.

Exclusion criteria

1. The best corrected visual acuity (BCVA) of \< 20/25 in each eye at far and near distances 2. Amblyopia patients or the difference of BCVA between the two eyes ≥ 2 lines 3. Constant strabismus patients 4. History of strabismus surgery or refractive surgery 5. Systemic diseases that would affect binocular vision 6. Acquired brain injury or neurological disorder.

Design outcomes

Primary

MeasureTime frameDescription
Binocular vision and visual function evaluation12 weeks for each participantChange 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026