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Clinical Trials/NCT03692728
NCT03692728CompletedNot Applicable

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

Sun Yat-sen University1 site in 1 country262 target enrollmentStarted: July 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
262
Locations
1
Primary Endpoint
Risk of ADHD

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
3 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haotian Lin

Prof.

Sun Yat-sen University

Study Sites (1)

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