The Cohort Study of Pediatric Cataract
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric Cataract. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Best-corrected visual acuity changes [Time frame: Baseline and through study completion, an average of 1 year]
- Intraocular pressure changes [Time frame: Baseline and through study completion, an average of 1 year]
- Refractive power changes [Time frame: Baseline and through study completion, an average of 1 year]
- Ocular biological measurements changes [Time frame: Baseline and through study completion, an average of 1 year]
- Incidence changes of postoperative complications [Time frame: Baseline and through study completion, an average of 1 year]
Secondary outcome measures (5)
- Other factors changes [Time frame: Baseline and through study completion, an average of 1 year]
- BMI changes [Time frame: Baseline and through study completion, an average of 1 year]
- Blood pressure changes [Time frame: Baseline and through study completion, an average of 1 year]
- Stereopsis changes [Time frame: Baseline and through study completion, an average of 1 year]
- Optical coherence tomography (OCT) changes [Time frame: Baseline and through study completion, an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhongshan Ophthalmic Center — Guangzhou
Publications
- 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. PMID 28465303
- 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. PMID 17003414
- 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. PMID 28539328
Identifiers
NCT: NCT05472844 · 2022KYPJ099