The Cohort Study of Pediatric Cataract

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Cohort Study of Pediatric Cataract

Conditions
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Pediatric Cataract

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity changes | Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time | Baseline and through study completion, an average of 1 year | 
| Intraocular pressure changes | Intraocular pressures are measured by NCT machine | Baseline and through study completion, an average of 1 year | 
| Refractive power changes | Refractive power are measured at baseline and every visit at least every 1 year | Baseline and through study completion, an average of 1 year | 
| Ocular biological measurements changes | Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance | Baseline and through study completion, an average of 1 year | 
| Incidence changes of postoperative complications | Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on | Baseline and through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other factors changes | Sleep, depression, cognitive function are measured by questionnaires. Self-Rating Scale of Sleep: minimum value-1 point, maximum value-50, and higher scores mean worse outcome. Hamilton Depression Scale: <7 points-normal, and higher scores mean worse outcome. Loewenstein Cognitive Assessment: for every question, minimum 1 point, and maximum 4 points. Higher scores mean worse outcomes. | Baseline and through study completion, an average of 1 year | 
| BMI changes | BMI is measured by technicians in every visit | Baseline and through study completion, an average of 1 year | 
| Blood pressure changes | Diastolic and systolic blood pressure are measured by technicians in every visit | Baseline and through study completion, an average of 1 year | 
| Stereopsis changes | Stereopsis is measured by Randot Stereotest | Baseline and through study completion, an average of 1 year | 
| Optical coherence tomography (OCT) changes | Retinal thickness is measured and analyzed by OCT | Baseline and through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ocular structure parameters, congenital cataract, traumatic cataract, complicated cataract, surgical/vision recovery timing and strategies, postoperative adverse effects, psychologic and cognitive function, artificial intelligence