CataractNCT02626416
Monitoring of Visual Axis Opacification Under Non-clinical Settings
A study testing LenZOC (mobile application) in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cataract
- What is being tested?
- LenZOC (mobile application)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Self-monitoring of Visual Axis Opacification (VAO) Under Non-clinical Settings in China
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.
Read the 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).
- Conditions
- Cataract
- Being tested
- LenZOC (mobile application)
- Keywords
- Telemedicine
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenZOC (mobile application)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| telemedicine group | Experimental | Congenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings Receives: Device: LenZOC (mobile application) |
| non-telemedicine group | No intervention | Congenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Times of follow-ups for each participant
Measured: up to one year
Secondary outcomes (1)
Best corrected visual acuity
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D. Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityYizhi Liu, M.D. Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityWeirong Chen, M.D., Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626416
- Sponsor's protocol ID
- CCPMOH2010-China10
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22921386Rivas-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.
PubMed 25204762Lin 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.
PubMed 26339020Plager 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.
PubMed 21925737Rong 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.
PubMed 26230501
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-monitoring of Visual Axis Opacification (VAO) Under Non-clinical Settings in China
- ClinicalTrials.gov ID
- NCT02626416
- Acronym / sponsor ID
- CCPMOH2010-China10
- Conditions
- Cataract
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine group | Experimental | Device: LenZOC (mobile application)Congenital cataract patients use telemedicine to pursue and adjust the time of follow-up under non-clinical settings |
| non-telemedicine group | No intervention | –Congenital cataract patients pursue and adjust the time of follow-up through outpatient visit in the hospital |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | telemedicine group |
Primary outcome
Times of follow-ups for each participant
Time frame: up to one year
1 secondary outcome
Best corrected visual acuity
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Background: PubMed 22921386Lin 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.
- Background: PubMed 25204762Rivas-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.
- Background: PubMed 26339020Lin 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.
- Background: PubMed 21925737Plager 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.
- Background: PubMed 26230501Rong 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.
- Home Page of Zhongshan Ophthalmic centerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, M.D. Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Yizhi Liu, M.D. Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen University
Weirong Chen, M.D. study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LenZOC (mobile application) in people with Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Times of follow-ups for each participant (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626416, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.