CataractNCT04138771
Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients
A study testing An artificial intelligence system for postoperative management of cataract patients in people with Cataract and Postoperative Complications, run by Sun Yat-sen University at 1 site in China.
Trial summary
Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract, Postoperative Complications, Artificial Intelligence
- What is being tested?
- An artificial intelligence system for postoperative management of cataract patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 1 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who had surgery of cataract extraction combined with introcular lens implantation.
- Patients should be aware of the contents and signed for the informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D, 8613802793086, haot.lin@hotmail.com
Xiaohang Wu, M.D., Ph.D, 8615913177657, wuxiaohang_zoc@qq.com
About this study
Official title: Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients: A Clinical Trial
Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.
- Being tested
- An artificial intelligence system for postoperative management of cataract patients
- Keywords
- Conjunctival hyperemia, Pterygium, Intraocular lens dislocation, Posterior capsule opacification, Pupil malformation, Suppurative endophthalmitis
- Medical subject headings
- Cataract, Postoperative Complications, Pterygium, Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An artificial intelligence system for postoperative management of cataract patientsDevice
This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients for AI test | Experimental | Device: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center. Receives: Device: An artificial intelligence system for postoperative management of cataract patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start1 Jan 2013
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China, Xidian University
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138771
- Sponsor's protocol ID
- CCPMOH2019-China-5
- Status last verified
- Dec 2019
- First submitted
- 23 Oct 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04138771
- Acronym / sponsor ID
- CCPMOH2019-China-5
- Keywords
- Conjunctival hyperemia, Pterygium, Intraocular lens dislocation, Posterior capsule opacification, Pupil malformation, Suppurative endophthalmitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China, Xidian University
- Study start
- 1 Jan 2013
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 24 Oct 2019 (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.
Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients for AI test | Experimental | Device: An artificial intelligence system for postoperative management of cataract patientsDevice: an artificial intelligence system for postoperative management of cataract patients. These patients are enrolled in primary healthcare units and the AI clinic at Zhongshan Ophthalmic Center. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who had surgery of cataract extraction combined with introcular lens implantation.
- Patients should be aware of the contents and signed for the informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| An artificial intelligence system for postoperative management of cataract patientsThis system can detect multiple postoperative complications of cataract patients and then provide a management strategy. | Device | Eligible patients for AI test |
Primary outcome
The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system.
Time frame: Up to 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
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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.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An artificial intelligence system for postoperative management of cataract patients in people with Cataract and Postoperative Complications, 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 2 inclusion and 0 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 3 Dec 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system. (time frame: Up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2019.