Congenital Cataract Morphological Classifications

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02748031
• Collaborator: Ministry of Health, China (Other)
• Enrollment: 1,050
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 43.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Cataract	Procedure: slit-lamp-adapted anterior segmental photography	N/A

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
• Actual Enrollment: 1050 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Congenital Cataract Morphological Classifications and Monitoring Using Slit-Lamp-Adapted Photography in CCPMOH
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eligible patients group	Procedure: slit-lamp-adapted anterior segmental photography; The eligible patients underwent pupil dilation and slit-lamp-adapted anterior segmental photography to electronically record and monitor the morphology of their cataractous lens.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 10 Years
• Sexes Eligible for Study: 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

• Glaucoma

• Traumatic or complicated cataracts

• Vitreous and retinal diseases

• Any previous surgeries, and contraindication for pupil dilation and sedation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University
• Ministry of Health, China

Investigators

• Study Director: Hantian Lin, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
• Study Chair: Yizhi Liu, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
• Principal Investigator: Erping Long, M.D., Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Home page of Zhongshan Ophthalmic Center

Publications

• 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.

• Responsible Party: Erping Long, Principal Investigator，Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT02748031
• Other Study ID Numbers: CCPMOH2016-China4
• First Posted: Apr 22, 2016
• Last Update Posted: Apr 22, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Erping Long, Principal Investigator，Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University: Congenital cataracts; Opacity location; Opacity shape; Classification; Clinical applicability
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Apr 22, 2016