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AzTrials

CataractNCT02748044

Validation of the Utility of Rare Disease Intelligence Platform

A study testing CC-Cruiser in people with Cataract and Artificial Intelligence, run by Sun Yat-sen University at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. The artificial intelligence for systematic clinical application has not yet been successfully validated. Read more about this study

Who is it for?
Ages Up to 80 years
Conditions the study is for
Cataract, Artificial Intelligence
What is being tested?
CC-Cruiser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
4 sitesChina
Study dates
Jan 2012to Apr 2016
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 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the collaborating hospital.

Who cannot join

  • -

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Department of Ophthalmology, Guangdong General Hospital, Guangdong Academy of Medical Sciences

    Guangzhou, Guangdong, 510080

  • Department of Ophthalmology, First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510405

  • Department of Ophthalmology, Qingyuan People's Hospital

    Qingyuan, Guangdong, 511518

Other trials in China

About this study

Official title: Validation of the Utility of Rare Disease Intelligence Platform: A Multicenter Cluster Clinical Trial

The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. The artificial intelligence for systematic clinical application has not yet been successfully validated. Currently, the main prevention strategy for rare diseases is to build specialized care centers. However, these centers are scattered, and their coverage is insufficient, resulting in inadequate health care among a large proportion of rare disease patients. Here, the investigators use "deep learning" to create CC-Cruiser, an intelligence agent involving three functional networks: "pick-up networks" for diagnostics, "evaluation networks" for risk stratification and "strategist networks" to provide assisted treatment decisions. The investigator also establish a cloud intelligence platform for multi-hospital collaboration and conduct clinical trial and website-based study to validate its versatility.

Being tested
CC-Cruiser
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC-CruiserDevice

    An artificial intelligence to make comprehensive evaluation and treatment decision of congenital cataracts

Study groups in NCT02748044
Study groupRoleWhat they receive
Eligible patients for CC-Cruiser testExperimentalNot described
Receives: Device: CC-Cruiser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of accurate, mistaken and miss detection of CC-Cruiser.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startJan 2012
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748044
Sponsor's protocol ID
CCPMOH2016-China3
Status last verified
Apr 2016
First submitted
13 Apr 2016
Last updated
22 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26339020

  • Lin H, Ouyang H, Zhu J, Huang S, Liu Z, Chen S, Cao G, Li G, Signer RA, Xu Y, Chung C, Zhang Y, Lin D, Patel S, Wu F, Cai H, Hou J, Wen C, Jafari M, Liu X, Luo L, Zhu J, Qiu A, Hou R, Chen B, Chen J, Granet D, Heichel C, Shang F, Li X, Krawczyk M, Skowronska-Krawczyk D, Wang Y, Shi W, Chen D, Zhong Z, Zhong S, Zhang L, Chen S, Morrison SJ, Maas RL, Zhang K, Liu Y. Lens regeneration using endogenous stem cells with gain of visual function. Nature. 2016 Mar 17;531(7594):323-8. doi: 10.1038/nature17181. Epub 2016 Mar 9.

    PubMed 26958831

Questions about this trial

What is this clinical trial studying?

A study testing CC-Cruiser in people with Cataract and Artificial Intelligence, run by Sun Yat-sen University at 4 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of accurate, mistaken and miss detection of CC-Cruiser. (time frame: Up to 4 years). 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 NCT02748044, which also lists 2 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 22 Apr 2016.

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