Monitoring of Visual Axis Opacification Under Non-clinical Settings

Sun Yat-sen University

Status: Unknown

Conditions: Cataract

Treatments: Device: LenZOC (mobile application)

Study type: Interventional

Funder types: Other

Identifiers

NCT02626416

CCPMOH2010-China10

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,400 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

telemedicine group

Experimental group

Description:

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

Treatment:

Device: LenZOC (mobile application)

non-telemedicine group

No Intervention group

Description:

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