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Assessing the Functional and Psychosocial Impact of Strabismus in Asian Children Using the AS-20 and IXTQ Questionnaires

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608828
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
Audrey Wei-Lin Chia, Singapore National Eye Centre

Brief Summary:

Studies suggest that strabismus has a negative impact on a person's self-image, interpersonal relationships, emotional and psychosocial state (4-15). There are, however, few such studies based in Asia, and the functional and psycho-social impact of disease is often neglected in our management of strabismus in Singapore. The aim of this pilot study is to measure quality-of-life (QOL) among strabismic children in Singapore so as to better understand the functional and psychosocial issues faced by these children in their daily living. The investigators also hope to evaluate the performance of the Intermittent Exotropia Questionnaire (IXTQ) (2) and Adult Strabismus Quality of Life Questionnaire (AS-20) (1) and to determine if differences between child and parental perceptions exist.

60 children with strabismus presenting to the KKWCH Eye Centre and their parents will be invited to participate in the study and answer questions in 2 Pediatric Eye Disease Investigator Group (PEDIG)-validated questionnaires (i.e. the IXTQ and AS-20). 30 children aged 5-7 years will answer the 12-question IXTQ (5-7 years), while 30 children aged 8-16 years will answer the 12-question IXTQ (8-16 years) and the 20-question AS-20 questionnaires. Their parents will answer the self-administered IXTQ child-proxy (12 questions), IXTQ parental (17 questions) and modified AS20 child-proxy questionnaires (20 questions). For comparison, 60 aged-matched children without strabismus or amblyopia (30 aged 5-7 years, and 30 aged 8-16) and their parents will also be invited to answer similar questionnaires (controls).

Results will be analysed question-by-question and then by composite score, and comparison will be made between child and parental-proxy measures, as well as with scores obtained from myopic children. It is hoped, that from this study, we will be able to assess the usefulness of the IXTQ and AS-20 instruments as measures of QOL in strabismic children, and to assess the feasibility of its use in a larger study looking at the impact of strabismus and its treatment in Singaporean children.

Condition or disease

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assessing the Functional and Psychosocial Impact of Strabismus in Asian Children Using the AS-20 and IXTQ Questionnaires
Actual Study Start Date : May 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Primary Outcome Measures :
  1. Quality of life in Asian children with strabismus [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children with strabismus

Inclusion Criteria:

  1. Children aged 5 to 16 years (inclusive) with strabismus or age-matched controls without strabismus/amblyopia
  2. Any tropia
  3. Willingness of children or parents willing to complete questionnaires
  4. Parents with sufficient reading skills to complete the English written IXTQ and AS20
  5. Parent/guardian able to provide informed consent

Exclusion Criteria:

  1. Children with poor vision (VA worse than 6/7.5) in either eye
  2. Children with any ocular, neurological or syndromic problems
  3. Children with developmental delay or mental impairment
  4. Children from overseas (not residing in Singapore)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608828

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KK Women and Children Hospital
Singapore, Singapore, 168753
Sponsors and Collaborators
Singapore National Eye Centre
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Responsible Party: Audrey Wei-Lin Chia, Senior Consultant, Singapore National Eye Centre Identifier: NCT01608828    
Other Study ID Numbers: 2012/350/A
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases