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The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency

The Health-Related Quality of Life of the Patients With Symptomatic Convergence Insufficiency

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05948046
Enrollment
300
Registered
2023-07-17
Start date
2022-06-01
Completion date
2024-06-30
Last updated
2023-07-17

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

Conditions

Convergence Insufficiency, Myopia

Brief summary

This trial is an observational cohort study. Patients aged 8-15 years with symptomatic convergence insufficiency and 150 patients with symptomatic convergence insufficiency who had not received visual training were selected from the Tianjin Eye Hospital Optometry Center and received 1 course of visual training treatment. Self-assessment and other assessments were combined, and the patient and guardian questionnaires were collected. The EQ-5D-Y and CHU9D scales were used to evaluate Chinese patients' health-related quality of life with symptomatic convergence insufficiency. The feasibility of the EQ-5D-Y and CHU9D scales in assessing the health-related quality of life of Chinese patients with symptomatic convergence insufficiency was analyzed. To assess the effectiveness of visual training on visual symptoms and improvement of quality of life in patients with symptomatic convergence insufficiency

Interventions

BEHAVIORALVisual training in hospital

Completion of 1 session of standardized visual training

Sponsors

Tianjin Eye Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years

Inclusion criteria

* 8\ 15 years old * Monocular best corrected visual acuity at distance and near was more than 0.8 * Near exophoria 4Δ greater than distance exophoria * NPC ≥ 6cm * PFV ≤15△BO * Stereogram ≤500 '' * Score of CISS questionnaire ≥16 or COVD questionnaire≥20

Exclusion criteria

* present constant strabismus, nystagmus or vertical phoria at distance or near. * developmental delay or ocular surgery * Myopia≤ -6.00D, Hyperopia ≥ +5.00D, Astigmatism ≥ 4.00D * Monocular Amplitude of accommodation\<5D * Other diseases except myopia

Design outcomes

Primary

MeasureTime frameDescription
Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) scoreThe changes between baseline and 3 monthsThe EQ-5D-5L questionnaires were used to evaluate the quality of life scores of myopic patients.The health utility value can be calculated by the number of the answer to the question. 0 means death and 1 means complete health.
Changes in shortForm 6D(SF-6D) questionnaire scoreThe changes between baseline and 3 monthsThe SF-6D questionnaires were used to evaluate the quality of life scores of myopic patients.The health utility value can be calculated by the number of the answer to the question. 0 means death and 1 means complete health.

Countries

China

Contacts

Primary ContactYue Zhang, MD
zhangyue_1225@126.com+862227306525

Outcome results

None listed

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