The Cohort Study of Pediatric Cataract
- Conditions
- Pediatric Cataract
- Registration Number
- NCT05472844
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent
- adults
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best-corrected visual acuity changes Baseline and through study completion, an average of 1 year Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
Ocular biological measurements changes Baseline and through study completion, an average of 1 year Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance
Incidence changes of postoperative complications Baseline and through study completion, an average of 1 year Incidence of postoperative complications, such as glaucoma-related adverse, myopic shift, strabismus and anisometropia and so on
Intraocular pressure changes Baseline and through study completion, an average of 1 year Intraocular pressures are measured by NCT machine
Refractive power changes Baseline and through study completion, an average of 1 year Refractive power are measured at baseline and every visit at least every 1 year
- Secondary Outcome Measures
Name Time Method BMI changes Baseline and through study completion, an average of 1 year BMI is measured by technicians in every visit
Other factors changes Baseline and through study completion, an average of 1 year 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.
Blood pressure changes Baseline and through study completion, an average of 1 year Diastolic and systolic blood pressure are measured by technicians in every visit
Stereopsis changes Baseline and through study completion, an average of 1 year Stereopsis is measured by Randot Stereotest
Optical coherence tomography (OCT) changes Baseline and through study completion, an average of 1 year Retinal thickness is measured and analyzed by OCT
Trial Locations
- Locations (1)
Zhongshan Ophthalmic Center
🇨🇳Guangzhou, Guangdong, China