CataractNCT03240848
Comparison of Artificial Intelligent Clinic and Normal Clinic
A study testing artificial intelligent clinic, normal clinic and experts diagnose in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this study, the investigators provide participants≤14 years old the artificial intelligent clinic or normal clinic in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of artificial… Read more about this study
- Who is it for?
- Ages 1 month to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- artificial intelligent clinic, normal clinic and experts diagnose
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2017to 25 May 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 1 month to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Paediatric patients from collaborating eye clinics Written informed consents provided
Who cannot join
- Definitive diagnosis of cataract or other ocular abnormalities Previous eye surgery Can not cooperate with the slip lamp examination Unwilling to participate in this trail
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: Comparison of Artificial Intelligent Clinic and Normal Clinic for Diagnosing Congenital Cataracts
In this study, the investigators provide participants≤14 years old the artificial intelligent clinic or normal clinic in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.
Read the detailed description
Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to two groups: participants in group A went to the artificial intelligent clinic and get the initial diagnosis, while in Group B, the participants went to the normal clinic. Investigators provide the final definite diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis, time consuming and the satisfaction level between two groups, aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.
- Conditions
- Cataract
- Being tested
- artificial intelligent clinic, normal clinic, experts diagnose
- Keywords
- congenital cataract, artificial intelligent clinic
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligent clinicProcedure or surgery
Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
normal clinicProcedure or surgery
Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
experts diagnoseProcedure or surgery
After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.
| Study group | Role | What they receive |
|---|---|---|
| artificial intelligent clinic | Experimental | Procedure: the initial diagnosis from artificial intelligent clinic Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
Procedure: the final definite diagnosis from experts After making the initial diagnosis in artificial intelligent clinic, participants in group A went to get the final definite diagnosis from experts with more than 10 years of clinical experience. Receives: Procedure: artificial intelligent clinic; Procedure: experts diagnose |
| normal clinic | Active comparator | Procedure: the initial diagnosis from normal clinic Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
Procedure: the final definite diagnosis from experts After making the initial diagnosis in normal clinic, participants in group B went to get the final definite diagnosis from experts with more than 10 years of clinical experience. Receives: Procedure: normal clinic; Procedure: experts diagnose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of artificial intelligence diagnosis for congenital cataract
The accuracy of artificial intelligence diagnosis was calculated.
Measured: baseline
Secondary outcomes (3)
The evaluation of disease severity and treatment determination
The accuracy of the evaluation of disease severity and treatment determination was calculated
Measured: baseline
The time consuming of diagnosis
The time consuming of diagnosis was calculated.
Measured: baseline
The level of patients' satisfaction
The information about patients' satisfaction was recorded by using a questionnaire.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start9 Aug 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240848
- Sponsor's protocol ID
- CCPMOH2017-China-5
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin H, Li R, Liu Z, Chen J, Yang Y, Chen H, Lin Z, Lai W, Long E, Wu X, Lin D, Zhu Y, Chen C, Wu D, Yu T, Cao Q, Li X, Li J, Li W, Wang J, Yang M, Hu H, Zhang L, Yu Y, Chen X, Hu J, Zhu K, Jiang S, Huang Y, Tan G, Huang J, Lin X, Zhang X, Luo L, Liu Y, Liu X, Cheng B, Zheng D, Wu M, Chen W, Liu Y. Diagnostic Efficacy and Therapeutic Decision-making Capacity of an Artificial Intelligence Platform for Childhood Cataracts in Eye Clinics: A Multicentre Randomized Controlled Trial. EClinicalMedicine. 2019 Mar 17;9:52-59. doi: 10.1016/j.eclinm.2019.03.001. eCollection 2019 Mar.
PubMed 31143882
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Artificial Intelligent Clinic and Normal Clinic for Diagnosing Congenital Cataracts
- ClinicalTrials.gov ID
- NCT03240848
- Acronym / sponsor ID
- CCPMOH2017-China-5
- Conditions
- Cataract
- Keywords
- congenital cataract, artificial intelligent clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 7 Aug 2017 (actual)
- 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.
In this study, the investigators provide participants≤14 years old the artificial intelligent clinic or normal clinic in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.
Detailed description
Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to two groups: participants in group A went to the artificial intelligent clinic and get the initial diagnosis, while in Group B, the participants went to the normal clinic. Investigators provide the final definite diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis, time consuming and the satisfaction level between two groups, aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artificial intelligent clinic | Experimental | Procedure: artificial intelligent clinic, Procedure: experts diagnoseProcedure: the initial diagnosis from artificial intelligent clinic Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment. Procedure: the final definite diagnosis from experts After making the initial diagnosis in artificial intelligent clinic, participants in group A went to get the final definite diagnosis from experts with more than 10 years of clinical experience. |
| normal clinic | Active comparator | Procedure: normal clinic, Procedure: experts diagnoseProcedure: the initial diagnosis from normal clinic Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment. Procedure: the final definite diagnosis from experts After making the initial diagnosis in normal clinic, participants in group B went to get the final definite diagnosis from experts with more than 10 years of clinical experience. |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Paediatric patients from collaborating eye clinics Written informed consents provided
Key exclusion criteria (1 listed)
- Definitive diagnosis of cataract or other ocular abnormalities Previous eye surgery Can not cooperate with the slip lamp examination Unwilling to participate in this trail
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 |
|---|---|---|
| artificial intelligent clinicParticipants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment. | Procedure or surgery | artificial intelligent clinic |
| normal clinicParticipants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment. | Procedure or surgery | normal clinic |
| experts diagnoseAfter making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience. | Procedure or surgery | artificial intelligent clinic, normal clinic |
Primary outcome
The accuracy of artificial intelligence diagnosis for congenital cataract
Time frame: baseline
The accuracy of artificial intelligence diagnosis was calculated.
3 secondary outcomes
The evaluation of disease severity and treatment determination
Time frame: baseline
The time consuming of diagnosis
Time frame: baseline
The level of patients' satisfaction
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Derived from this study: PubMed 31143882Lin H, Li R, Liu Z, Chen J, Yang Y, Chen H, Lin Z, Lai W, Long E, Wu X, Lin D, Zhu Y, Chen C, Wu D, Yu T, Cao Q, Li X, Li J, Li W, Wang J, Yang M, Hu H, Zhang L, Yu Y, Chen X, Hu J, Zhu K, Jiang S, Huang Y, Tan G, Huang J, Lin X, Zhang X, Luo L, Liu Y, Liu X, Cheng B, Zheng D, Wu M, Chen W, Liu Y. Diagnostic Efficacy and Therapeutic Decision-making Capacity of an Artificial Intelligence Platform for Childhood Cataracts in Eye Clinics: A Multicentre Randomized Controlled Trial. EClinicalMedicine. 2019 Mar 17;9:52-59. doi: 10.1016/j.eclinm.2019.03.001. eCollection 2019 Mar.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligent clinic, normal clinic and experts diagnose 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 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 30 Jul 2018. 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?
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 accuracy of artificial intelligence diagnosis for congenital cataract (time frame: baseline). 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 NCT03240848, which also lists 1 linked publication.
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 30 Jul 2018.