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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cataract

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Zhenzhen Liu, PhD; Phone Number: +020 66618932; Email: liuzhenzhen@gzzoc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: Zhenzhen Liu, PhD; Phone Number: +020 66618932; Email: liuzhenzhen@gzzoc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective-prospective bidirectional cohort study. Patients aged < 18 yo at the 1st visit are enrolled.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General 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. Erratum In: Arch Dis Child. 2017 Oct;102(10):995.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2022
• Primary Completion (ANTICIPATED): January 1, 2032
• Study Completion (ANTICIPATED): February 1, 2032

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (ACTUAL): July 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: artificial intelligence; congenital cataract; traumatic cataract; complicated cataract; ocular structure parameters; surgical/vision recovery timing and strategies; postoperative adverse effects; psychologic and cognitive function
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2022KYPJ099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No