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Congenital Cataract Morphological Classifications

Primary Purpose

Congenital Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
slit-lamp-adapted anterior segmental photography
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Cataract focused on measuring Congenital cataracts, Opacity location, Opacity shape, Classification, Clinical applicability

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

eligible patients group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2016
Last Updated
April 21, 2016
Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China
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1. Study Identification

Unique Protocol Identification Number
NCT02748031
Brief Title
Congenital Cataract Morphological Classifications
Official Title
Congenital Cataract Morphological Classifications and Monitoring Using Slit-Lamp-Adapted Photography in CCPMOH
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Ministry of Health, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Lens opacities in congenital cataracts have a wide range of presentations.Therefore, it is important to find a method of recording, classifying and monitoring cataract morphologies that is feasible and safe in a large cohort of children with congenital cataracts, including uncooperative children. Photography is considered as one of the most important means to promote evidence-based medical practice in pediatric ophthalmology. In this study, the investigators studied congenital cataract morphological classifications and monitoring using slit-lamp-adapted anterior segmental photography and evaluated its safety and feasibility in pediatric cataract patients registered in the Childhood Cataract Program of the Chinese Ministry of Health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
Congenital cataracts, Opacity location, Opacity shape, Classification, Clinical applicability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eligible patients group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
slit-lamp-adapted anterior segmental photography
Intervention Description
The eligible patients underwent pupil dilation and slit-lamp-adapted anterior segmental photography to electronically record and monitor the morphology of their cataractous lens.
Primary Outcome Measure Information:
Title
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with pediatric unilateral/bilateral cataracts Children who were younger than 10 years of age Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hantian Lin, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erping Long, M.D., Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22921386
Citation
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.
Results Reference
background
PubMed Identifier
29134133
Citation
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.
Results Reference
derived
Links:
URL
http://www.gzzoc.com/
Description
Home page of Zhongshan Ophthalmic Center

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Congenital Cataract Morphological Classifications

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