Congenital Cataract Morphological Classifications

Not Applicable

Completed

• Conditions: Congenital Cataract

• Registration Number: NCT02748031
• Lead Sponsor: Sun Yat-sen University

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 Timeline

• Study Start: 2014-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-17
• Study First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Study First Posted: 2016-04-22
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1050

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Congenital Cataract Morphological Classifications and Monitoring using Slit-Lamp-Adapted Photography	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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China