Increased Risk of ADHD Among Children With Bilateral Congenital Cataracts

Increased Risk of Attention Deficit Hyperactivity Disorder Among Children With Bilateral Congenital Cataracts

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.

Study Overview

• Status: Completed
• Conditions: Childhood Cataract
• Intervention / Treatment: Other: Psychological and Behavioral Problems

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

hospital-based

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of ADHD	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.	2016.7-12

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: September 29, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (ACTUAL): October 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: attention deficit hyperactivity disorder; congenital cataract; Conners'Parent Rating Scale-48
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Lens Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Cataract; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: CCPMOH2018- China9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No