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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
70mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Aug 2022Feb 2032

First Submitted

Initial submission to the registry

June 6, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

August 22, 2022

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2032

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2032

Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

9.4 years

First QC Date

June 6, 2022

Last Update Submit

September 26, 2022

Conditions

Pediatric Cataract

Keywords

congenital cataracttraumatic cataractcomplicated cataractocular structure parameterssurgical/vision recovery timing and strategiespostoperative adverse effectspsychologic and cognitive functionartificial intelligence

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • Other factors changes

    Baseline and through study completion, an average of 1 year

  • BMI changes

    Baseline and through study completion, an average of 1 year

  • Blood pressure changes

    Baseline and through study completion, an average of 1 year

  • Stereopsis changes

    Baseline and through study completion, an average of 1 year

  • Optical coherence tomography (OCT) changes

    Baseline and through study completion, an average of 1 year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • aged \< 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent

You may not qualify if:

  • adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (3)

  • 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: 28465303BACKGROUND

  • 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: 17003414BACKGROUND

  • 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: 28539328BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Capsule Opacification

Condition Hierarchy (Ancestors)

CataractLens DiseasesEye Diseases

Study Officials

  • Yizhi Liu, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Liu, PhD

CONTACT

+020 66618932liuzhenzhen@gzzoc.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2022

First Posted

July 25, 2022

Study Start

August 22, 2022

Primary Completion (Estimated)

January 1, 2032

Study Completion (Estimated)

February 1, 2032

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)