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

May 2, 2017 updated by: Audrey Wei-Lin Chia, Singapore National Eye Centre

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168753
        • KK Women and Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with strabismus

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life in Asian children with strabismus
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

May 28, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (ESTIMATE)

May 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/350/A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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