Monitoring of Visual Axis Opacification Under Non-clinical Settings

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02626416
Collaborator
(none)
1,400
1
2
24
58.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LenZOC (mobile application)
N/A

Detailed Description

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. 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Self-monitoring of Visual Axis Opacification (VAO) Under Non-clinical Settings in China
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: telemedicine group

Congenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings

Device: 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).

No Intervention: non-telemedicine group

Congenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital

Outcome Measures

Primary Outcome Measures

  1. Times of follow-ups for each participant [up to one year]

Secondary Outcome Measures

  1. Best corrected visual acuity [up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Haotian Lin, Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT02626416
Other Study ID Numbers:
  • CCPMOH2010-China10
First Posted:
Dec 10, 2015
Last Update Posted:
Dec 10, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Haotian Lin, Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2015