NCT02748031

Brief Summary

Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology.This study is to investigate the feasibility of congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography in a large cohort that included uncooperative children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

April 17, 2016

Last Update Submit

April 21, 2016

Conditions

Congenital Cataract

Keywords

Congenital cataractsOpacity locationOpacity shapeClassificationClinical applicability

Outcome Measures

Primary Outcomes (1)

  • Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography

    All eligible pediatric patients underwent pupil dilation with compound tropicamide eye drops 3 times (1 time every 10 minutes) before the examination or administration of sleep aid medicine. Then, the children underwent slit-lamp-adapted anterior segmental photography (BX900, Haag-Streit AG, Köniz, Switzerland) for each cataractous lens, including one diffuse light photo, one slit-light photo across the cataract and one retro-illumination photo. All photos of the included patients were screened and morphologically classified separately by two pediatric ophthalmologists; a third ophthalmologist was masked and required to make a decision if the first two physicians had different opinions.

    baseline

Study Arms (1)

eligible patients group

EXPERIMENTAL
Procedure: slit-lamp-adapted anterior segmental photography

Interventions

slit-lamp-adapted anterior segmental photographyPROCEDURE

The eligible patients underwent pupil dilation and slit-lamp-adapted anterior segmental photography to electronically record and monitor the morphology of their cataractous lens.

eligible patients group

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with pediatric unilateral/bilateral cataracts
  • Children who were younger than 10 years of age

You may not qualify if:

  • Premature birth
  • Microphthalmia
  • Micro-or Megalocornea
  • Keratoconus
  • Glaucoma
  • Traumatic or complicated cataracts
  • Vitreous and retinal diseases
  • Any previous surgeries, and contraindication for pupil dilation and sedation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

  • Lin H, Chen W, Luo L, Congdon N, Zhang X, Zhong X, Liu Z, Chen W, Wu C, Zheng D, Deng D, Ye S, Lin Z, Zou X, Liu Y. Effectiveness of a short message reminder in increasing compliance with pediatric cataract treatment: a randomized trial. Ophthalmology. 2012 Dec;119(12):2463-70. doi: 10.1016/j.ophtha.2012.06.046. Epub 2012 Aug 24.

    PMID: 22921386BACKGROUND

  • Long E, Lin Z, Chen J, Liu Z, Cao Q, Lin H, Chen W, Liu Y. Monitoring and Morphologic Classification of Pediatric Cataract Using Slit-Lamp-Adapted Photography. Transl Vis Sci Technol. 2017 Nov 2;6(6):2. doi: 10.1167/tvst.6.6.2. eCollection 2017 Nov.

    PMID: 29134133DERIVED

Related Links

Study Officials

  • Hantian Lin, M.D., Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

  • Yizhi Liu, M.D., Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

  • Erping Long, M.D., Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator，Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

April 17, 2016

First Posted

April 22, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations

CN(1)