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Clinical Trials/NCT05948046
NCT05948046
Recruiting
Not Applicable

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

Tianjin Eye Hospital1 site in 1 country300 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Tianjin Eye Hospital
Enrollment
300
Locations
1
Primary Endpoint
Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
June 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in EuroQol five dimensions questionnaire(EQ-5D-5L) score

Time Frame: The changes between baseline and 3 months

The 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 score

Time Frame: The changes between baseline and 3 months

The 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.

Study Sites (1)

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