Monitoring of Visual Axis Opacification Under Non-clinical Settings
NCT ID: NCT02626416
Last Updated: 2015-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1400 participants
INTERVENTIONAL
2016-01-31
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. In this way, patients and/or guardians could adjust the time of return to clinical follow-up visit accordingly. Furthermore, standardized and analyzed pictures could be sent to clinicians for remote diagnosis when necessary.
The investigators developed a mobile phone application LenZOC. The investigators aimed to assess whether mobile phone application for parents of children with cataracts would improve their adherence with follow-up and increase rates of timely detection and management of treatable conditions such as posterior capsular opacification (PCO).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
telemedicine group
Congenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings
LenZOC (mobile application)
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).
non-telemedicine group
Congenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LenZOC (mobile application)
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Without other ocular abnormality
* Parents owned a smart mobile phone that meets the requirements for installation of the LenZOC
* Written informed consents provided
Exclusion Criteria
* Pre-existing ocular diseases including but not restricted to:
Glucoma Micro-cornea Micro-ophthalmic Diseases of post-segment that might lead to VAO
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Haotian Lin
Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Haotian Lin, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D. Ph.D.
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D.
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Rivas-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.
Lin 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.
Plager 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.
Rong 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.
Related Links
Access external resources that provide additional context or updates about the study.
Home Page of Zhongshan Ophthalmic center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CCPMOH2010-China10
Identifier Type: -
Identifier Source: org_study_id