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Completed

NCT Number: NCT03692728

Increased Risk of ADHD 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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychological and Behavioral Problems

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2018
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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