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Monitoring of Visual Axis Opacification Under Non-clinical Settings

NCT02626416 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2015-12-10

No results posted yet for this study

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.

Conditions

  • Cataract

Interventions

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).

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Haotian Lin, M.D. Ph.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

  • Yizhi Liu, M.D. Ph.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

  • Weirong Chen, M.D. · Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626416 on ClinicalTrials.gov