Clinical trial NCT05472844: The Cohort Study of Pediatric Cataract
Official title: The Cohort Study of Pediatric Cataract
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Cataract
Keywords: congenital cataract
traumatic cataract
complicated cataract
ocular structure parameters
surgical/vision recovery timing and strategies
postoperative adverse effects
psychologic and cognitive function
artificial intelligence
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 5000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective-prospective bidirectional cohort study. Patients aged \< 18 yo at the 1st visit are enrolled.

Brief summary: This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.

Detailed description: Pediatric cataract, one of the leading causes of childhood blindness globally, is complex and of great difficulty in treatment. Pediatric patients with cataract (congenital, traumatic or complicated) are enrolled. In this study, investigators will compare ocular parameter changes, different surgical/vision timing or recovery strategies and adverse effects among young children （age \< 18 yo）before and after cataract surgery. The influence on psychology and cognitive function will be taken into consideration as well. The whole blood samples of participants and parents are collected and retained in our biobank for gene sequencing, hoping to explore the genetic factors in association with pathogenesis. For children received cataract surgery, samples of partial anterior capsular tissue and 1 ml aqueous humor were collected during operation for further analysis. Multimodal artificial intelligence analyses are performed to establish accurate diagnosis/treatment scheme and disease prediction model.

Eligibility criteria: Inclusion Criteria:

* aged \< 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent

Exclusion Criteria:

* adults

Primary outcomes:
measure: Best-corrected visual acuity changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Intraocular pressure changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Refractive power changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Ocular biological measurements changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Incidence changes of postoperative complications
timeFrame: Baseline and through study completion, an average of 1 year
Secondary outcomes:
measure: Other factors changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: BMI changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Blood pressure changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Stereopsis changes
timeFrame: Baseline and through study completion, an average of 1 year
measure: Optical coherence tomography (OCT) changes
timeFrame: Baseline and through study completion, an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solebo AL, Teoh L, Rahi J. Epidemiology of blindness in children. Arch Dis Child. 2017 Sep;102(9):853-857. doi: 10.1136/archdischild-2016-310532. Epub 2017 May 2.
citation: Chak M, Wade A, Rahi JS; British Congenital Cataract Interest Group. Long-term visual acuity and its predictors after surgery for congenital cataract: findings of the British congenital cataract study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4262-9. doi: 10.1167/iovs.05-1160.
citation: Long E, Zhang X, Liu Z, Wu X, Tan X, Lin D, Cao Q, Chen J, Lin Z, Wang D, Li X, Li J, Wang J, Li W, Lin H, Chen W, Liu Y. Dynamic response to initial stage blindness in visual system development. Clin Sci (Lond). 2017 Jun 28;131(13):1515-1527. doi: 10.1042/CS20170234. Print 2017 Jul 1.