The Cohort Study of Pediatric Cataract

Pediatric Cataract Clinical Trial

Official title:

The Cohort Study of Pediatric Cataract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472844
• Other study ID #: 2022KYPJ099
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: February 1, 2032

Study information

• Verified date: September 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Zhenzhen Liu, PhD
• Phone: +020 66618932
• Email: liuzhenzhen[@]gzzoc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: February 1, 2032
• Est. primary completion date: January 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Pediatric Cataract

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. Review. Erratum in: Arch Dis Child. 2017 Oct;102(10):995. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Intraocular pressure changes	Intraocular pressures are measured by NCT machine	Baseline and through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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	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
Secondary	BMI changes	BMI is measured by technicians in every visit	Baseline and through study completion, an average of 1 year
Secondary	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
Secondary	Stereopsis changes	Stereopsis is measured by Randot Stereotest	Baseline and through study completion, an average of 1 year
Secondary	Optical coherence tomography (OCT) changes	Retinal thickness is measured and analyzed by OCT	Baseline and through study completion, an average of 1 year