Age-related CataractNCT04246346
Effectiveness of Using Interactive Consulting System to Enhance Informed Choice
A study testing An interactive chatbot for patient decision aid and Senior ophthalmologists in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- An interactive chatbot for patient decision aid and Senior ophthalmologists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2023
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 45-80 years who have been resident in the selected study district for more than six months;
- A definite diagnosis of age-related cataract;
- Having not received cataract surgery;
- Willing to participate the study and provide informed consent.
Who cannot join
- Bilateral blindness (presenting distance visual acuity worse than 3/60);
- Having ocular, hearing or mental disorders precluding reading or telephone interview;
- Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
- Having cataract surgery contraindication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yingfeng Zheng, M.D, Ph.D, +8613922286455, zhyfeng@mail.sysu.edu.cn
About this study
Official title: Effectiveness of Using Interactive Consulting System Based on Large Language Model to Enhance Informed Choice of Cataract Patients: a Non-inferiority Randomized Controlled Trial
To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.
Read the detailed description
Cataract surgery is the only way to treat age-related cataract. For patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. Therefore the patients are uaually not aware whether they should receive the surgery. The number of trained and qualified ophthalmologists are limited in China and lots of patients cannot have detailed consultation with ophthalmologists. As a result, many patients still have doubts about whether they should receive cataract surgery or not. In this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.
- Conditions
- Age-related Cataract
- Being tested
- An interactive chatbot for patient decision aid, Senior ophthalmologists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An interactive chatbot for patient decision aidOther
A chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
Senior ophthalmologistsOther
Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| Interactive chatbot | Experimental | A chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery. Receives: Other: An interactive chatbot for patient decision aid |
| Senior ophthalmologists | Active comparator | Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery. Receives: Other: Senior ophthalmologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
Informed choice is an aggregated measure of multiple measurements, including knowledge (a 12-item questionnaire that assesses conceptual (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses)
Measured: 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Sep 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
- Investigators
- Yingfeng Zheng, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246346
- Sponsor's protocol ID
- 2020KYPJ003
- Status last verified
- Oct 2023
- First submitted
- 23 Jan 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified will be shared after the study being published.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Interactive Consulting System Based on Large Language Model to Enhance Informed Choice of Cataract Patients: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04246346
- Acronym / sponsor ID
- 2020KYPJ003
- Conditions
- Age-related Cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Jan 2020 (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.
To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.
Detailed description
Cataract surgery is the only way to treat age-related cataract. For patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. Therefore the patients are uaually not aware whether they should receive the surgery. The number of trained and qualified ophthalmologists are limited in China and lots of patients cannot have detailed consultation with ophthalmologists. As a result, many patients still have doubts about whether they should receive cataract surgery or not. In this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive chatbot | Experimental | Other: An interactive chatbot for patient decision aidA chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery. |
| Senior ophthalmologists | Active comparator | Other: Senior ophthalmologistsSenior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 45-80 years who have been resident in the selected study district for more than six months;
- A definite diagnosis of age-related cataract;
- Having not received cataract surgery;
- Willing to participate the study and provide informed consent.
Key exclusion criteria (4 listed)
- Bilateral blindness (presenting distance visual acuity worse than 3/60);
- Having ocular, hearing or mental disorders precluding reading or telephone interview;
- Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
- Having cataract surgery contraindication.
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 interactive chatbot for patient decision aidA chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery. | Other | Interactive chatbot |
| Senior ophthalmologistsSenior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery. | Other | Senior ophthalmologists |
Primary outcome
Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
Time frame: 2 weeks post intervention
Informed choice is an aggregated measure of multiple measurements, including knowledge (a 12-item questionnaire that assesses conceptual (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: Yes. Deidentified will be shared after the study being published.
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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.
Yingfeng Zheng, MD, PhD 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 An interactive chatbot for patient decision aid and Senior ophthalmologists in people with Age-related 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 4 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 26 Oct 2023. 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?
Contact Yingfeng Zheng, MD, PhD (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score) (time frame: 2 weeks post intervention). 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 26 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.