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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Singapore National Eye Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Audrey Wei-Lin Chia, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01608828
First received: May 28, 2012
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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
Strabismus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Quality of life in Asian children with strabismus [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children with strabismus

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608828

Contacts
Contact: Audrey Chia, FRANZCO 65-63741938 wla_chia@yahoo.com

Locations
Singapore
KK Women and Children Hospital Recruiting
Singapore, Singapore, 168753
Principal Investigator: Audrey Chia, FRANZCO         
Sponsors and Collaborators
Singapore National Eye Centre
  More Information

No publications provided

Responsible Party: Audrey Wei-Lin Chia, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01608828     History of Changes
Other Study ID Numbers: 2012/350/A
Study First Received: May 28, 2012
Last Updated: May 31, 2012
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014