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Completed

NCT Number: NCT02748031

Congenital Cataract Morphological Classifications

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.

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Key information

Conditions

Congenital Cataract

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

slit-lamp-adapted anterior segmental photography

Procedure

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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Ministry of Health, China

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2016
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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