Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Recruiting
NCT Number: NCT05472844
The Cohort Study of Pediatric Cataract
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Best-corrected visual acuity changes
Time frame: 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
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Intraocular pressure changes
Time frame: Baseline and through study completion, an average of 1 year
Intraocular pressures are measured by NCT machine
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Refractive power changes
Time frame: Baseline and through study completion, an average of 1 year
Refractive power are measured at baseline and every visit at least every 1 year
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Ocular biological measurements changes
Time frame: 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
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Incidence changes of postoperative complications
Time frame: 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
Secondary outcomes
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Other factors changes
Time frame: 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.
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BMI changes
Time frame: Baseline and through study completion, an average of 1 year
BMI is measured by technicians in every visit
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Blood pressure changes
Time frame: Baseline and through study completion, an average of 1 year
Diastolic and systolic blood pressure are measured by technicians in every visit
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Stereopsis changes
Time frame: Baseline and through study completion, an average of 1 year
Stereopsis is measured by Randot Stereotest
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Optical coherence tomography (OCT) changes
Time frame: Baseline and through study completion, an average of 1 year
Retinal thickness is measured and analyzed by OCT
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
Registry information
Important dates
- Study start
- 2022
- Primary completion
- 2032
- Study completion
- 2032
- First posted
- Jul 25, 2022
- Registry last updated
- Sep 27, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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