Monitoring of Visual Axis Opacification Under Non-clinical Settings
Self-monitoring of Visual Axis Opacification (VAO) Under Non-clinical Settings in China
1 other identifier
interventional
1,400
1 country
1
Brief Summary
The incidence rate of postoperative capsular opacification (PCO) in children after cataract surgery is reported to be as high as 100%, while timely Nd: YAG laser posterior capsulotomy is effective to treat visual axis opacification (VAO) caused by PCO. Therefore, long-term follow-up, timely diagnosis and treatment is important to improve patient's outcome. The major and central part of lens is easy to be observed through a dilated pupil. Especially, opacification in the lens and/or lens capsule is distinctive showing as "white" on the "black" background. The characteristic features of the disease and advances in photographic technique with mobile phone make it possible for patients and/or their guardians to monitor the progress of cataract or PCO with mobile application in a "self-help" manner under non-clinical settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedDecember 10, 2015
December 1, 2015
2 years
December 7, 2015
December 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Times of follow-ups for each participant
up to one year
Secondary Outcomes (1)
Best corrected visual acuity
up to 24 weeks
Study Arms (2)
telemedicine group
EXPERIMENTALCongenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings
non-telemedicine group
NO INTERVENTIONCongenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital
Interventions
The transparency of the visual axial at the anterior segment is observed through a dilated pupil. Image of the eye of a patient taken with LenZOC is calibrated with a standardized white and black bar adhered to the patient's eyelid. Calibrated images are dimmed as graysalegrayscale. The intensity and progress of visual axial opacification (VAO) is quantified as absolute area and relative area (calculated as: absolute area of VAO/ absolute area of dilated pupil).
Eligibility Criteria
You may qualify if:
- Children after cataract surgery for more than 1 year without any postoperative complications
- Without other ocular abnormality
- Parents owned a smart mobile phone that meets the requirements for installation of the LenZOC
- Written informed consents provided
You may not qualify if:
- Intraocular pressure \>21 mmHg
- Pre-existing ocular diseases including but not restricted to:
- Glucoma Micro-cornea Micro-ophthalmic Diseases of post-segment that might lead to VAO
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Related Publications (5)
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.
PMID: 22921386BACKGROUNDRivas-Perea P, Baker E, Hamerly G, Shaw BF. Detection of leukocoria using a soft fusion of expert classifiers under non-clinical settings. BMC Ophthalmol. 2014 Sep 9;14:110. doi: 10.1186/1471-2415-14-110.
PMID: 25204762BACKGROUNDLin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.
PMID: 26339020BACKGROUNDPlager DA, Lynn MJ, Buckley EG, Wilson ME, Lambert SR; Infant Aphakia Treatment Study Group. Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology. 2011 Dec;118(12):2330-4. doi: 10.1016/j.ophtha.2011.06.017. Epub 2011 Sep 16.
PMID: 21925737BACKGROUNDRong X, Ji Y, Fang Y, Jiang Y, Lu Y. Long-Term Visual Outcomes of Secondary Intraocular Lens Implantation in Children with Congenital Cataracts. PLoS One. 2015 Jul 31;10(7):e0134864. doi: 10.1371/journal.pone.0134864. eCollection 2015.
PMID: 26230501BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haotian 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
- STUDY DIRECTOR
Weirong Chen, M.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 10, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
December 10, 2015
Record last verified: 2015-12