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OpenTrials
Enrolling by Invitation

NCT Number: NCT07317661

Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options

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.

Enrolling by Invitation

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Key information

Conditions

Eye Disorders Cataract Cataract Extraction Cataract Surgery Cataract Surgery Experience Cataract and IOL Surgery Eye Diseases Intraocular Lens Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute

Palo Alto, California, 94303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

LLM-based Education

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient satisfaction scale score as measured by Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: Same Day of Enrollment up to 2 hours

    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.

  2. Percentage of Monofocal Lens Chosen as IOL of Choice Between Arms

    Time frame: Up to 4 weeks post enrollment

    The intraocular lens chosen on day of surgery, grouped as monofocal or non-monofocal, will be documented post-surgery implantation.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Effectiveness of a Large Language Model-Based Educational Tool on Intraocular Lens Options: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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