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Increased Risk of ADHD Among Children With Bilateral Congenital Cataracts

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ClinicalTrials.gov Identifier: NCT03692728
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, Sun Yat-sen University

Brief Summary:
In this study, the investigators conducted a cross-sectional, face-to-face investigation to evaluate the behavioral and psychological disorders and the risk of ADHD among children with bilateral congenital cataracts using the Conners'Parent Rating Scale (CPRS) questionnaire, an assessment tool for screening ADHD that obtains parental reports of childhood behavioral problems in research and clinical settings.15-17 Age-matched children with normal vision and the Chinese urban norm were used as controls.

Condition or disease Intervention/treatment
Childhood Cataract Other: Psychological and Behavioral Problems

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Study Type : Observational
Actual Enrollment : 262 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Increased Risk of Attention Deficit Hyperactivity Disorder Among Children With Bilateral Congenital Cataracts
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
CC children
CC children were registered members of the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH). All of them were diagnosed with CC by two experienced pediatric ophthalmologists based on a comprehensive evaluation of the onset age (within one year after birth), morphological features of lens opacity, family history, and detailed medical records.
Other: Psychological and Behavioral Problems
Differences in age and sex between the CC and NV groups were compared using the independent samples t test and Chi-square test, respectively. Comparisons of abnormal rates between the CC and NV groups were performed using the Chi-square test. Scores on all subscales recorded for the CC group were compared with those of the NV group and the Chinese urban norm using the independent samples t test and one-sample t test, respectively.

NV children
NV children were recruited from the Optometry Department of the ZOC as the control group. NV was defined as BCVA ≥0.3 (log MAR) in children between 3-5 years old or BCVA ≥0.15 (log MAR) in children older than 5 years. Children with strabismus and high refractive error (myopia or hyperopia: >6.0 Diopters; astigmatism: >3.0 Diopters) were excluded from NV group.
Other: Psychological and Behavioral Problems
Differences in age and sex between the CC and NV groups were compared using the independent samples t test and Chi-square test, respectively. Comparisons of abnormal rates between the CC and NV groups were performed using the Chi-square test. Scores on all subscales recorded for the CC group were compared with those of the NV group and the Chinese urban norm using the independent samples t test and one-sample t test, respectively.




Primary Outcome Measures :
  1. Risk of ADHD [ Time Frame: 2016.7-12 ]
    The Conners' Parent Rating Scale 48 (CPRS-48) contains 5 evaluating subscales, including the conduct problems, learning problems, psychosomatic, impulsiveness/hyperactivity, and anxiety subscales. A total of 48 items are included in the questionnaire, and each item is scored from 0 to 3 (0 represents the best, 3 represents the worst). The final scores of the 5 subscales are defined as the mean scores of the corresponding items: conduct problems (2+8+14+19+20+21+22+23+27+33+34+39)/12; learning problems (10+25+31+37)/4; psychosomatic (32+41+43+44+48)/5; impulsiveness/hyperactivity (4+5+11+13)/4; anxiety (12+16+24+47)/4; and the hyperactivity index (4+7+11+13+14+25+31+33+37+38)/10. Final scores and the five subscales of the CPRS-48 between two groups were compared.



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
hospital-based
Criteria

Inclusion Criteria:

  • CC children and NV children aged 3-8 years presenting to the Zhognshan Ophthalmic Center between July and December 2016.

Exclusion Criteria:

  • Patients complicated with systemic manifestations, such as Lowe syndrome, Marfan syndrome, and Down syndrome, were excluded.

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 ClinicalTrials.gov identifier (NCT number): NCT03692728


Locations
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China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Haotian Lin, Prof., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03692728     History of Changes
Other Study ID Numbers: CCPMOH2018- China9
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Haotian Lin, Sun Yat-sen University:
congenital cataract
attention deficit hyperactivity disorder
Conners'Parent Rating Scale-48

Additional relevant MeSH terms:
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Cataract
Attention Deficit Disorder with Hyperactivity
Lens Diseases
Eye Diseases
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders