OphthalmologyAINCT03310216
The Clinical Application of Artificial Intelligent(AI) Visual Inspection System
A study testing Order I of visual inspection and Order II of visual inspection in people with Ophthalmology, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this study, the investigators provide participants from ophthalmic clinic the AI visual inspection system and EDTRS in the purpose of seeking out a better way of visual inspection with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of AI visual inspection… Read more about this study
- Who is it for?
- Ages 1 month to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ophthalmology
- What is being tested?
- Order I of visual inspection and Order II of visual inspection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Oct 2017to Dec 2017
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients≤90 years old from ophthalmic clinic; Written informed consents provided
Who cannot join
- Can not cooperate with the visual inspection; Unwilling to participate in this trail
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Jing Li, M.D, +86-20-87330341, Reviewborad_SYsU@163.com
Haotian Lin, M.D,Ph.D
About this study
Official title: The Clinical Application of Artificial Intelligent Visual Inspection System
In this study, the investigators provide participants from ophthalmic clinic the AI visual inspection system and EDTRS in the purpose of seeking out a better way of visual inspection with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of AI visual inspection system and EDTRS for visual inspection.
Read the detailed description
Patients ≤90 years old from ophthalmic clinic are enrolled to a prospective, randomized controlled study. Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later. All of the visual inspection methods will be repeated two times. Investigators compare the accuracy and repeatability of the AI visual inspection system, time consuming, costs and the satisfaction level between two groups.
- Conditions
- Ophthalmology
- Being tested
- Order I of visual inspection, Order II of visual inspection
- Keywords
- artificial intelligent, visual inspection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order I of visual inspectionProcedure or surgery
Participants in group I are provided AI visual inspection system first and EDTRS later.
Order II of visual inspectionProcedure or surgery
The participants in Group II are provided EDTRS first and AI visual inspection system later.
| Study group | Role | What they receive |
|---|---|---|
| Order I of visual inspection | Experimental | Participants in group I are provided AI visual inspection system first and EDTRS later. Receives: Procedure: Order I of visual inspection |
| Order II of visual inspection | Active comparator | Participants in group II are provided EDTRS first and AI visual inspection system later. Receives: Procedure: Order II of visual inspection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of AI visual inspection system
The accuracy of AI visual inspection system was calculated.
Measured: Baseline
Secondary outcomes (2)
The time taken of visual inspection
The time taken of visual inspection was calculated.
Measured: Baseline
Costs of AI visual inspection system
Costs of AI visual inspection system was calculated.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study startOct 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies 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
- Crossover
- Model description
- Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310216
- Sponsor's protocol ID
- CCPMOH2017-China-8
- Acronym
- AI
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 16 Oct 2017
- 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 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application of Artificial Intelligent Visual Inspection System
- ClinicalTrials.gov ID
- NCT03310216
- Acronym / sponsor ID
- AI / CCPMOH2017-China-8
- Conditions
- Ophthalmology
- Keywords
- artificial intelligent, visual inspection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Oct 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 from ophthalmic clinic the AI visual inspection system and EDTRS in the purpose of seeking out a better way of visual inspection with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of AI visual inspection system and EDTRS for visual inspection.
Detailed description
Patients ≤90 years old from ophthalmic clinic are enrolled to a prospective, randomized controlled study. Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later. All of the visual inspection methods will be repeated two times. Investigators compare the accuracy and repeatability of the AI visual inspection system, time consuming, costs and the satisfaction level between two groups.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are assigned to two groups: participants in group I are provided AI visual inspection system first and EDTRS later, while in Group II, the participants are provided EDTRS first and AI visual inspection system later.
| Arm | Type | Receives |
|---|---|---|
| Order I of visual inspection | Experimental | Procedure: Order I of visual inspectionParticipants in group I are provided AI visual inspection system first and EDTRS later. |
| Order II of visual inspection | Active comparator | Procedure: Order II of visual inspectionParticipants in group II are provided EDTRS first and AI visual inspection system later. |
Who may qualify
- Ages
- 1 month to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients≤90 years old from ophthalmic clinic; Written informed consents provided
Key exclusion criteria (1 listed)
- Can not cooperate with the visual inspection; 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 |
|---|---|---|
| Order I of visual inspectionParticipants in group I are provided AI visual inspection system first and EDTRS later. | Procedure or surgery | Order I of visual inspection |
| Order II of visual inspectionThe participants in Group II are provided EDTRS first and AI visual inspection system later. | Procedure or surgery | Order II of visual inspection |
Primary outcome
The accuracy of AI visual inspection system
Time frame: Baseline
The accuracy of AI visual inspection system was calculated.
2 secondary outcomes
The time taken of visual inspection
Time frame: Baseline
Costs of AI visual inspection system
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Order I of visual inspection and Order II of visual inspection in people with Ophthalmology, 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: status not confirmed, as of the sponsor's last update on 16 Oct 2017. 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 accuracy of AI visual inspection system (time frame: Baseline). 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 16 Oct 2017.