Eye DisordersNCT07317661
Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options
A study testing LLM-based Education in people with Eye Disorders and Cataract Extraction, run by Stanford University at 1 site in United States.
Trial summary
Patients with cataracts disease need to choose what type of artificial lens will go into their eye prior to surgery date. Some lenses are standard and are usually covered by insurance. Other "premium" lenses have various benefits such as reducing the need for glasses but usually require out-of-pocket costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Disorders, Cataract Extraction, Cataract and IOL Surgery
- What is being tested?
- LLM-based Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Presenting for cataract evaluation or preoperative cataract counseling in the ophthalmology clinic
- Able to provide informed consent
- English-speaking
- No prior cataract surgery in either eye (so that all patients are making a first-eye IOL decision)
Who cannot join
- Any cognitive impairment or hearing impairment that prevents meaningful counseling or survey completion
- Urgent ocular condition requiring immediate attention that would override routine cataract counseling (for example, acute retinal detachment)
- Patient declines or is unable to complete the brief post-visit survey
- Has ocular conditions that would impact eligibility of non-monofocal lens options
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options: A Randomized Controlled Trial
Patients with cataracts disease need to choose what type of artificial lens will go into their eye prior to surgery date. Some lenses are standard and are usually covered by insurance. Other "premium" lenses have various benefits such as reducing the need for glasses but usually require out-of-pocket costs.
The combined busy outpatient clinic and complexity of artificial lens choices in the ever-changing world of cataract surgery tends to lead patients confused about their available lens options. There is an abundance of educational material present in premium lenses, however these are limited by accessibility and are standardized at single educational levels.
Read more
Therefore in the present study, we want to test whether giving patients a short LLM powered AI-guided explanation from Custom GPT from OpenAI of lens options prior to their consultation with their doctor can improve visit efficiency, physician explanation and patient understanding of lens options. We will compare two groups: standard of care versus standard of care plus AI education.
The LLM in this study is intended to provide supplemental information about premium intraocular lens(IOLs) options to study participants, and is no means supposed to replace a health care professional in the diagnosis, cure, treatment, and/or mitigation of disease. Study is analogous to giving a verified health pamphlet to a patient for them to view and learn different IOL options, in other words, facilitating patient understanding of their options.
The LLM will be trained by several health care professionals and MD specialists to provide sufficient instructions. Sources will include verified online resources and MD information.
The investigators hope to learn if a large language model-based educational tool can improve visit efficiency, physician explanation and patient understanding of intraocular lens options. New knowledge of this study could guide how cataract counseling is delivered in the future and may help clinics spend more time on individualized questions instead of repeating generic information.
- Conditions
- Eye Disorders, Cataract Extraction, Cataract and IOL Surgery, Cataract Surgery Experience, Cataract Surgery, Intraocular Lens
- Being tested
- LLM-based Education
- Keywords
- LLM, AI, GPT, ChatGPT, Custom GPT, CustomGPT, education, LLM-based education
- Medical subject headings
- Eye Diseases, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM-based EducationOther
Participants will receive audio education powered by a large language model (LLM) before seeing the fellow or attending physician. The LLM will be presented using a 10 inch tablet or laptop device by a trained research team member. The interaction is intended to be self-guided, with no interference from the staff unless the LLM displays incorrect or "hallucinated" content. In such cases, the research staff will immediately correct any misinformation and record the occurrence, including details and frequency of the hallucination, for quality monitoring. The LLM module will deliver educational material about intraocular lens options and answer any questions the study participant has. This LLM-based education is for research purposes only. Afterward, participants will proceed to their scheduled visit.
| Study group | Role | What they receive |
|---|---|---|
| LLM-based Education + Standard of Care | Experimental | * Before seeing the fellow, the participant will listen to a short, structured LLM powered AI-delivered educational session with Custom GPT (10 minutes or less). The intractable AI script explains standard monofocal IOLs and premium options (toric, extended depth of focus, multifocal, light adjustable lens), including benefits, trade-offs, and out-of-pocket costs.
* The AI module may allow the patient to ask clarifying questions within scope of that script. This AI session is not currently part of standard care and is considered the experimental intervention.
* The participant takes a patient satisfaction (CSQ-8) after their clinical visit with the fellow and attending Receives: Other: LLM-based Education |
| Standard of Care | No intervention | * The participant skips the AI module and proceeds directly to routine fellow and attending counseling, which reflects current standard of care practice. * The participant takes a patient satisfaction (CSQ-8) after their clinical visit with the fellow and attending physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Consultation Time
Total consultation time of both fellow and attending physician in their visit with the study participant will be recorded in minutes.
Measured: Same Day of Enrollment up to 2 hours
Secondary outcomes (2)
Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8)
4-point ordinal Likert-type response options. The total CSQ 8 score will be used as a continuous outcome, with higher scores indicating greater satisfaction.
Measured: Same Day of Enrollment up to 2 hours
Percentage of Monofocal Lens Chosen as IOL of Choice Between Arms
The intraocular lens chosen on day of surgery, grouped as monofocal or non-monofocal, will be documented post-surgery implantation.
Measured: Up to 4 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DisordersStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert T. Chang, MD, Stanford University
- Investigators
- Robert T Chang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317661
- Sponsor's protocol ID
- 82807
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07317661
- Acronym / sponsor ID
- 82807
- Conditions
- Eye Disorders, Cataract Extraction, Cataract and IOL Surgery, Cataract Surgery Experience, Cataract Surgery, Intraocular Lens
- Keywords
- LLM, AI, GPT, ChatGPT, Custom GPT, CustomGPT, education, LLM-based education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
Patients with cataracts disease need to choose what type of artificial lens will go into their eye prior to surgery date. Some lenses are standard and are usually covered by insurance. Other "premium" lenses have various benefits such as reducing the need for glasses but usually require out-of-pocket costs.
The combined busy outpatient clinic and complexity of artificial lens choices in the ever-changing world of cataract surgery tends to lead patients confused about their available lens options. There is an abundance of educational material present in premium lenses, however these are limited by accessibility and are standardized at single educational levels.
Therefore in the present study, we want to test whether giving patients a short LLM powered AI-guided explanation from Custom GPT from OpenAI of lens options prior to their consultation with their doctor can improve visit efficiency, physician explanation and patient understanding of lens options. We will compare two groups: standard of care versus standard of care plus AI education.
The LLM in this study is intended to provide supplemental information about premium intraocular lens(IOLs) options to study participants, and is no means supposed to replace a health care professional in the diagnosis, cure, treatment, and/or mitigation of disease. Study is analogous to giving a verified health pamphlet to a patient for them to view and learn different IOL options, in other words, facilitating patient understanding of their options.
The LLM will be trained by several health care professionals and MD specialists to provide sufficient instructions. Sources will include verified online resources and MD information.
The investigators hope to learn if a large language model-based educational tool can improve visit efficiency, physician explanation and patient understanding of intraocular lens options. New knowledge of this study could guide how cataract counseling is delivered in the future and may help clinics spend more time on individualized questions instead of repeating generic information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM-based Education + Standard of Care | Experimental | Other: LLM-based Education* Before seeing the fellow, the participant will listen to a short, structured LLM powered AI-delivered educational session with Custom GPT (10 minutes or less). The intractable AI script explains standard monofocal IOLs and premium options (toric, extended depth of focus, multifocal, light adjustable lens), including benefits, trade-offs, and out-of-pocket costs. * The AI module may allow the patient to ask clarifying questions within scope of that script. This AI session is not currently part of standard care and is considered the experimental intervention. * The participant takes a patient satisfaction (CSQ-8) after their clinical visit with the fellow and attending |
| Standard of Care | No intervention | –* The participant skips the AI module and proceeds directly to routine fellow and attending counseling, which reflects current standard of care practice. * The participant takes a patient satisfaction (CSQ-8) after their clinical visit with the fellow and attending physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Presenting for cataract evaluation or preoperative cataract counseling in the ophthalmology clinic
- Able to provide informed consent
- English-speaking
- No prior cataract surgery in either eye (so that all patients are making a first-eye IOL decision)
Key exclusion criteria (4 listed)
- Any cognitive impairment or hearing impairment that prevents meaningful counseling or survey completion
- Urgent ocular condition requiring immediate attention that would override routine cataract counseling (for example, acute retinal detachment)
- Patient declines or is unable to complete the brief post-visit survey
- Has ocular conditions that would impact eligibility of non-monofocal lens options
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 |
|---|---|---|
| LLM-based EducationParticipants will receive audio education powered by a large language model (LLM) before seeing the fellow or attending physician. The LLM will be presented using a 10 inch tablet or laptop device by a trained research team member. The interaction is intended to be self-guided, with no interference from the staff unless the LLM displays incorrect or "hallucinated" content. In such cases, the research staff will immediately correct any misinformation and record the occurrence, including details and frequency of the hallucination, for quality monitoring. The LLM module will deliver educational material about intraocular lens options and answer any questions the study participant has. This LLM-based education is for research purposes only. Afterward, participants will proceed to their scheduled visit. | Other | LLM-based Education + Standard of Care |
Primary outcome
Total Consultation Time
Time frame: Same Day of Enrollment up to 2 hours
Total consultation time of both fellow and attending physician in their visit with the study participant will be recorded in minutes.
2 secondary outcomes
Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: Same Day of Enrollment up to 2 hours
Percentage of Monofocal Lens Chosen as IOL of Choice Between Arms
Time frame: Up to 4 weeks post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Robert T Chang, MD principal investigator
Stanford 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 LLM-based Education in people with Eye Disorders and Cataract Extraction, run by Stanford University at 1 site in United States.
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 5 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: enrolling by invitation, as of the sponsor's last update on 5 Jan 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total Consultation Time (time frame: Same Day of Enrollment up to 2 hours). 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 5 Jan 2026.