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Monitoring of Visual Axis Opacification Under Non-clinical Settings

Primary Purpose

Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LenZOC (mobile application)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Telemedicine

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhognshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

telemedicine group

non-telemedicine group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Times of follow-ups for each participant

Secondary Outcome Measures

Best corrected visual acuity

Full Information

First Posted
December 7, 2015
Last Updated
December 7, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02626416
Brief Title
Monitoring of Visual Axis Opacification Under Non-clinical Settings
Official Title
Self-monitoring of Visual Axis Opacification (VAO) Under Non-clinical Settings in China
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
telemedicine group
Arm Type
Experimental
Arm Description
Congenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings
Arm Title
non-telemedicine group
Arm Type
No Intervention
Arm Description
Congenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital
Intervention Type
Device
Intervention Name(s)
LenZOC (mobile application)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Times of follow-ups for each participant
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D. Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yizhi Liu, M.D. Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Weirong Chen, M.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22921386
Citation
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.
Results Reference
background
PubMed Identifier
25204762
Citation
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.
Results Reference
background
PubMed Identifier
26339020
Citation
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.
Results Reference
background
PubMed Identifier
21925737
Citation
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.
Results Reference
background
PubMed Identifier
26230501
Citation
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.
Results Reference
background
Links:
URL
http://www.gzzoc.com
Description
Home Page of Zhongshan Ophthalmic center

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Monitoring of Visual Axis Opacification Under Non-clinical Settings

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