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Clinical Trials/NCT02748031
NCT02748031CompletedNot Applicable

Congenital Cataract Morphological Classifications and Monitoring Using Slit-Lamp-Adapted Photography in CCPMOH

Sun Yat-sen University1 site in 1 country1,050 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,050
Locations
1
Primary Endpoint
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
— to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Traumatic or complicated cataracts
  • •Vitreous and retinal diseases
  • •Any previous surgeries, and contraindication for pupil dilation and sedation

Arms & Interventions

eligible patients group

Experimental

Intervention: slit-lamp-adapted anterior segmental photography (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: baseline

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erping Long

Principal Investigator,Home for Cataract Children, Zhongshan Ophthalmic Center

Sun Yat-sen University

Study Sites (1)

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