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

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608828
• Other study ID #: 2012/350/A
• Status: Completed
• Phase: N/A
• First received: May 28, 2012
• Last updated: May 2, 2017
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2017
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Strabismus

Locations

Country	Name	City	State
Singapore	KK Women and Children Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life in Asian children with strabismus		1 year