CataractNCT06528509
AI-Enhanced Consent for Cataract Surgery
A study testing AI-Generated Informative Videos and Standard Written Information Brochures in people with Cataract, run by Moorfields Eye Hospital NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This research focuses on enhancing the informed process for patients before undergoing cataract surgery. Currently, this process involves verbal discussions and written materials that may not fully address patients' understanding of the surgery, its risks, and benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- AI-Generated Informative Videos and Standard Written Information Brochures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Sep 2024to 11 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have capacity to consent
- Listed for first time cataract surgery
- English speakers for Cohort A
- Bengali speakers for Cohort B
Who cannot join
- Previously undergone cataract surgery
- Partner who has undergone cataract surgery
- Below the age of 18
- Unable to utilise a device for watching information videos and completing quiz
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Moorfields Eye Hospital Stratford
London, E15 4BQ
Swan Kang, MBBS, MBioch (Oxon), FRCOphth
Sara Memon, MBBS, BSc
Moorfields Eye Hospital
London, EC1V 2PD
Swan Kang, MBBS, MBioch (Oxon), FRCOphth, 07958585904, swan.kang1@nhs.net
Sara Memon, MBBS, BSc
About this study
Official title: An Artificial-intelligence-powered Intervention to Aid the Informed Consent Process for Cataract Surgery for English Speaking and Bengali Speaking Patient Population Groups: A Mixed-methods Randomised Control Trial
This research focuses on enhancing the informed process for patients before undergoing cataract surgery. Currently, this process involves verbal discussions and written materials that may not fully address patients' understanding of the surgery, its risks, and benefits. This study aims to introduce an innovative approach using artificial intelligence (AI) to generate informative videos tailored to patients' needs, accounting for education level, ethnicity, and language barriers.
Why is this important? Informed consent is not just a legal requirement; but it's a fundamental patient right. Ensuring patients truly understand their treatment options leads to better satisfaction, both from the patient and clinician's perspective.
Read more
This study compares the effectiveness of AI-generated videos against traditional information delivery methods (information brochures). Patients scheduled for cataract surgery will experience either the new AI video approach or the standard process. The goal is to see if the videos lead to better understanding of the procedure and overall satisfaction. The investigators will be running the study in two parallel cohorts - with Cohort A involving an English speaking population, and Cohort B a Bengali speaking population with all patient facing materials translated into Bengali.
This research is crucial for patients seeking clarity about cataract surgery, for doctors aiming to improve patient care, and for researchers exploring patient education innovations. Funded by the Medical Protection Society (MPS), the investigators hope this intervention has broader effects such as reducing the number of complaints and litigations, improving the efficiency of consenting for surgery and delivering information, and improving theatre utilisation by reducing last minute cancellations.
Read the detailed description
Background and Rationale
Cataract surgery is one of the most frequently performed procedures in the NHS, yet the process of obtaining informed consent remains a significant challenge. Traditional methods of informed consent, primarily involving verbal discussions and written materials, often fail to ensure that patients fully understand the surgery, its risks, and benefits. This is especially problematic for patients with limited health literacy, language barriers, or other socioeconomic factors that affect their ability to comprehend complex medical information.
Objectives
The primary objective of this study is to enhance the informed consent process for cataract surgery by using artificial intelligence (AI) to create personalized informative videos. These videos will be tailored to meet the specific needs of patients, taking into account their educational levels, language preferences, and cultural backgrounds. The AI-generated videos will be compared against traditional information delivery methods, such as verbal briefings and written brochures, to assess their effectiveness in improving patient understanding, satisfaction, and reducing anxiety.
Study Design
This study will be conducted with two cohorts, each targeting different patient demographics to assess the feasibility and effectiveness of the AI intervention.
Cohort A:
Focus on English-proficient patients. Participants will be randomized into two groups: one receiving the AI-generated video and the other receiving standard written brochures.
Cohort B:
Expand to a Bengali speaking population with limited English proficiency. Same randomized design as Cohort A.
Methods
Participants will be recruited from Moorfields Eye Hospital and will include 100 patients in each cohort. The study will use a mixed-methods approach, incorporating both quantitative and qualitative data collection.
Quantitative Measures:
A multiple-choice questionnaire will assess patient understanding of the surgery.
State Trait Anxiety Inventory (STAI) will measure patient anxiety levels. Time and motion studies will track the duration of information delivery and consent confirmation processes.
Cancellation rates and incidence of complaints or litigations will be recorded.
Qualitative Measures:
Semi-structured interviews will explore patient experiences with the information delivery methods, their engagement with digital tools, and their overall satisfaction with the consent process.
Anticipated Benefits:
- Improved patient understanding of cataract surgery, leading to higher satisfaction and reduced anxiety.
- Potential reduction in surgery cancellations and complaints, improving overall theatre utilization.
- Enhanced clinician satisfaction by streamlining the consent process and reducing the likelihood of malpractice claims.
Ethical Considerations:
The study will ensure that all AI-generated content is rigorously reviewed for accuracy and cultural sensitivity. Participants will be informed about the AI nature of the videos, and all data will be handled in compliance with GDPR regulations to ensure confidentiality and security. All materials in Cohort B will be checked by a native Bengali speaker with a medical background. The investigators will be using a validated Bengali translation of the State Trait Anxiety Inventory (STAI).
Dissemination Strategy
Findings from the study will be disseminated through various channels, including academic publications, presentations at national and international conferences, and reports to relevant healthcare authorities. The results will also be shared with participants and the broader public through social media and community engagement initiatives.
- Conditions
- Cataract
- Being tested
- AI-Generated Informative Videos, Standard Written Information Brochures
- Keywords
- Cataract surgery, Complaints, Litigation, Informed consent
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Informative VideosBehavioural
Participants in the experimental arm will receive an AI-generated video designed to provide comprehensive information about cataract surgery. The video will cover key aspects of the procedure, including the nature of the surgery, potential risks, benefits, and postoperative care. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B.
The video will be delivered to participants via a secure link sent to their mobile devices or email. Patients can watch the video at their convenience, and they are encouraged to view it as many times as necessary to fully understand the information provided. The video link will be provided once after the initial clinic appointment, but patients can access and watch the video multiple times.
The videos will be created using the Synthesia platform, which uses artificial intelligence to generate realistic, photo-realistic digital avatars that deliver the information in a personalized and engaging manner.
Standard Written Information BrochuresBehavioural
Participants in the control arm will receive traditional written information brochures about cataract surgery. These brochures are designed to deliver detailed and essential information in a clear and understandable format. The brochures will be handed to participants during their face-to-face clinic appointment. Patients can read the material at their convenience and keep it for future reference. These brochures follow standardized guidelines and recommendations to ensure that all relevant information is included and presented in an accessible manner. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B.
| Study group | Role | What they receive |
|---|---|---|
| AI-Generated Informative Videos | Experimental | Participants in this arm will receive an AI-generated informative video. The video will provide comprehensive information about cataract surgery, including the procedure, risks, benefits, and postoperative care. The content will be generated using the Synthesia platform, which uses artificial intelligence to create realistic, photo-realistic digital avatars to deliver the information. The aim is to improve patient understanding, satisfaction, and reduce preoperative anxiety compared to traditional information delivery methods. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B. Receives: Behavioral: AI-Generated Informative Videos |
| Standard Written Information Brochures | Active comparator | Participants in this arm will receive the standard information provided to patients undergoing cataract surgery, which consists of written information brochures. These brochures include comprehensive details about the cataract surgery procedure, potential risks, benefits, and postoperative care. The brochures are designed to provide all necessary information to help patients make an informed decision regarding their surgery. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B. Receives: Behavioral: Standard Written Information Brochures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information understanding and retention
Assessed via a 12-question multiple-choice quiz sent via text message one week after the initial appointment.
Measured: One week after intervention
Secondary outcomes (7)
Patient Anxiety Level
Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery.
Measured: Baseline; pre-intervention
Patient Anxiety Level
Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery.
Measured: On day of surgery
Time and Motion Study
Time taken for information delivery and consent confirmation on the day of surgery will be recorded.
Measured: On day of surgery
Participant-reported engagement time with the information material
This will be added as a question following the information understanding and retention quiz.
Measured: One week after intervention
Cancellation rates
Day-of surgery and short notice cancellation rates and reasons will be documented.
Measured: Within 7 days of surgery
Incidence of incidents and complaints
Any complaints or formal claims related to the surgery will be followed up for 12 months post-operatively
Measured: Up to 12 months post-operatively
Patient and clinician satisfaction: Assessed on the surgery day using a 5-point Likert scale Patient and clinician satisfaction
Assessed on the surgery day using a 5-point Likert scale
Measured: On day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start11 Sep 2024 (estimated)
- Primary completion11 Sep 2025 (estimated)
- Study completion11 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- 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
- Model description
- The study is designed as a parallel, randomized controlled trial. Participants scheduled for cataract surgery are randomly allocated into two groups: the intervention group and the control group. The intervention group receives AI-generated informative videos, while the control group receives standard written information brochures. The study will run in two cohorts, with Cohort A including English speaking patients and Cohort B Bengali speakers.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Protection Society Foundation
- Responsible party
- Sponsor
- Investigators
- Swan Kang, MBBS, MBioch (Oxon), FRCOphth, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528509
- Sponsor's protocol ID
- KANS1002
- Status last verified
- Jul 2024
- First submitted
- 5 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers. This decision is based on concerns about participant privacy and confidentiality, as well as the sensitive nature of the data collected in this study such as patient anxiety levels, and complaints and litigations. Instead, we will disseminate aggregated findings through peer-reviewed publications and presentations, ensuring the protection of participant identities while sharing valuable insights with the scientific community.
Publications
Ali N, Little BC. Causes of cataract surgery malpractice claims in England 1995-2008. Br J Ophthalmol. 2011 Apr;95(4):490-2. doi: 10.1136/bjo.2010.182774. Epub 2010 Aug 30.
PubMed 20805130Zhang Y, Ruan X, Tang H, Yang W, Xian Z, Lu M. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:9593631. doi: 10.1155/2017/9593631. Epub 2017 Jan 16.
PubMed 28191349Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012 Jan;38(1):80-4. doi: 10.1016/j.jcrs.2011.07.030. Epub 2011 Nov 6.
PubMed 22062774Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM. A randomized, controlled trial of video supplementation on the cataract surgery informed consent process. Graefes Arch Clin Exp Ophthalmol. 2019 Aug;257(8):1719-1728. doi: 10.1007/s00417-019-04372-5. Epub 2019 May 30.
PubMed 31144057Wagner SK, Raja L, Cortina-Borja M, Huemer J, Struyven R, Keane PA, Balaskas K, Sim DA, Thomas PBM, Rahi JS, Solebo AL, Kang S. Determinants of non-attendance at face-to-face and telemedicine ophthalmic consultations. Br J Ophthalmol. 2024 Mar 20;108(4):625-632. doi: 10.1136/bjo-2022-322389.
PubMed 37217292Bhan A, Dave D, Vernon SA, Bhan K, Bhargava J, Goodwin H; Medical Defence Union; Medical Protection Society; Medical and Dental Defence Union of Scotland. Risk management strategies following analysis of cataract negligence claims. Eye (Lond). 2005 Mar;19(3):264-8. doi: 10.1038/sj.eye.6701493.
PubMed 15286671Mathew RG, Ferguson V, Hingorani M. Clinical negligence in ophthalmology: fifteen years of national health service litigation authority data. Ophthalmology. 2013 Apr;120(4):859-64. doi: 10.1016/j.ophtha.2012.01.009. Epub 2012 Mar 2.
PubMed 22386949Ali N. A decade of clinical negligence in ophthalmology. BMC Ophthalmol. 2007 Dec 20;7:20. doi: 10.1186/1471-2415-7-20.
PubMed 18096077Gill ZS, Caldwell AS, Patnaik JL, Marin AI, Mudie LI, Grove N, Ifantides C, Ertel MK, Puente MA, Seibold LK. Comparison of cataract surgery outcomes in English proficient and limited English proficiency patients. J Cataract Refract Surg. 2023 Jun 1;49(6):595-601. doi: 10.1097/j.jcrs.0000000000001164.
PubMed 36779806Patel DN, Wakeam E, Genoff M, Mujawar I, Ashley SW, Diamond LC. Preoperative consent for patients with limited English proficiency. J Surg Res. 2016 Feb;200(2):514-22. doi: 10.1016/j.jss.2015.09.033. Epub 2015 Oct 3.
PubMed 26541685
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Artificial-intelligence-powered Intervention to Aid the Informed Consent Process for Cataract Surgery for English Speaking and Bengali Speaking Patient Population Groups: A Mixed-methods Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06528509
- Acronym / sponsor ID
- KANS1002
- Conditions
- Cataract
- Keywords
- Cataract surgery, Complaints, Litigation, Informed consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Medical Protection Society Foundation
- Study start
- 11 Sep 2024 (estimated)
- Primary completion
- 11 Sep 2025 (estimated)
- Study completion
- 11 Sep 2026 (estimated)
- First posted
- 30 Jul 2024 (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.
This research focuses on enhancing the informed process for patients before undergoing cataract surgery. Currently, this process involves verbal discussions and written materials that may not fully address patients' understanding of the surgery, its risks, and benefits. This study aims to introduce an innovative approach using artificial intelligence (AI) to generate informative videos tailored to patients' needs, accounting for education level, ethnicity, and language barriers.
Why is this important? Informed consent is not just a legal requirement; but it's a fundamental patient right. Ensuring patients truly understand their treatment options leads to better satisfaction, both from the patient and clinician's perspective.
This study compares the effectiveness of AI-generated videos against traditional information delivery methods (information brochures). Patients scheduled for cataract surgery will experience either the new AI video approach or the standard process. The goal is to see if the videos lead to better understanding of the procedure and overall satisfaction. The investigators will be running the study in two parallel cohorts - with Cohort A involving an English speaking population, and Cohort B a Bengali speaking population with all patient facing materials translated into Bengali.
This research is crucial for patients seeking clarity about cataract surgery, for doctors aiming to improve patient care, and for researchers exploring patient education innovations. Funded by the Medical Protection Society (MPS), the investigators hope this intervention has broader effects such as reducing the number of complaints and litigations, improving the efficiency of consenting for surgery and delivering information, and improving theatre utilisation by reducing last minute cancellations.
Detailed description
Background and Rationale
Cataract surgery is one of the most frequently performed procedures in the NHS, yet the process of obtaining informed consent remains a significant challenge. Traditional methods of informed consent, primarily involving verbal discussions and written materials, often fail to ensure that patients fully understand the surgery, its risks, and benefits. This is especially problematic for patients with limited health literacy, language barriers, or other socioeconomic factors that affect their ability to comprehend complex medical information.
Objectives
The primary objective of this study is to enhance the informed consent process for cataract surgery by using artificial intelligence (AI) to create personalized informative videos. These videos will be tailored to meet the specific needs of patients, taking into account their educational levels, language preferences, and cultural backgrounds. The AI-generated videos will be compared against traditional information delivery methods, such as verbal briefings and written brochures, to assess their effectiveness in improving patient understanding, satisfaction, and reducing anxiety.
Study Design
This study will be conducted with two cohorts, each targeting different patient demographics to assess the feasibility and effectiveness of the AI intervention.
Cohort A:
Focus on English-proficient patients. Participants will be randomized into two groups: one receiving the AI-generated video and the other receiving standard written brochures.
Cohort B:
Expand to a Bengali speaking population with limited English proficiency. Same randomized design as Cohort A.
Methods
Participants will be recruited from Moorfields Eye Hospital and will include 100 patients in each cohort. The study will use a mixed-methods approach, incorporating both quantitative and qualitative data collection.
Quantitative Measures:
A multiple-choice questionnaire will assess patient understanding of the surgery.
State Trait Anxiety Inventory (STAI) will measure patient anxiety levels. Time and motion studies will track the duration of information delivery and consent confirmation processes.
Cancellation rates and incidence of complaints or litigations will be recorded.
Qualitative Measures:
Semi-structured interviews will explore patient experiences with the information delivery methods, their engagement with digital tools, and their overall satisfaction with the consent process.
Anticipated Benefits:
- Improved patient understanding of cataract surgery, leading to higher satisfaction and reduced anxiety.
- Potential reduction in surgery cancellations and complaints, improving overall theatre utilization.
- Enhanced clinician satisfaction by streamlining the consent process and reducing the likelihood of malpractice claims.
Ethical Considerations:
The study will ensure that all AI-generated content is rigorously reviewed for accuracy and cultural sensitivity. Participants will be informed about the AI nature of the videos, and all data will be handled in compliance with GDPR regulations to ensure confidentiality and security. All materials in Cohort B will be checked by a native Bengali speaker with a medical background. The investigators will be using a validated Bengali translation of the State Trait Anxiety Inventory (STAI).
Dissemination Strategy
Findings from the study will be disseminated through various channels, including academic publications, presentations at national and international conferences, and reports to relevant healthcare authorities. The results will also be shared with participants and the broader public through social media and community engagement initiatives.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a parallel, randomized controlled trial. Participants scheduled for cataract surgery are randomly allocated into two groups: the intervention group and the control group. The intervention group receives AI-generated informative videos, while the control group receives standard written information brochures. The study will run in two cohorts, with Cohort A including English speaking patients and Cohort B Bengali speakers.
| Arm | Type | Receives |
|---|---|---|
| AI-Generated Informative Videos | Experimental | Behavioral: AI-Generated Informative VideosParticipants in this arm will receive an AI-generated informative video. The video will provide comprehensive information about cataract surgery, including the procedure, risks, benefits, and postoperative care. The content will be generated using the Synthesia platform, which uses artificial intelligence to create realistic, photo-realistic digital avatars to deliver the information. The aim is to improve patient understanding, satisfaction, and reduce preoperative anxiety compared to traditional information delivery methods. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B. |
| Standard Written Information Brochures | Active comparator | Behavioral: Standard Written Information BrochuresParticipants in this arm will receive the standard information provided to patients undergoing cataract surgery, which consists of written information brochures. These brochures include comprehensive details about the cataract surgery procedure, potential risks, benefits, and postoperative care. The brochures are designed to provide all necessary information to help patients make an informed decision regarding their surgery. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have capacity to consent
- Listed for first time cataract surgery
- English speakers for Cohort A
- Bengali speakers for Cohort B
Key exclusion criteria (4 listed)
- Previously undergone cataract surgery
- Partner who has undergone cataract surgery
- Below the age of 18
- Unable to utilise a device for watching information videos and completing quiz
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 |
|---|---|---|
| AI-Generated Informative VideosParticipants in the experimental arm will receive an AI-generated video designed to provide comprehensive information about cataract surgery. The video will cover key aspects of the procedure, including the nature of the surgery, potential risks, benefits, and postoperative care. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B. The video will be delivered to participants via a secure link sent to their mobile devices or email. Patients can watch the video at their convenience, and they are encouraged to view it as many times as necessary to fully understand the information provided. The video link will be provided once after the initial clinic appointment, but patients can access and watch the video multiple times. The videos will be created using the Synthesia platform, which uses artificial intelligence to generate realistic, photo-realistic digital avatars that deliver the information in a personalized and engaging manner. | Behavioural | AI-Generated Informative Videos |
| Standard Written Information BrochuresParticipants in the control arm will receive traditional written information brochures about cataract surgery. These brochures are designed to deliver detailed and essential information in a clear and understandable format. The brochures will be handed to participants during their face-to-face clinic appointment. Patients can read the material at their convenience and keep it for future reference. These brochures follow standardized guidelines and recommendations to ensure that all relevant information is included and presented in an accessible manner. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B. | Behavioural | Standard Written Information Brochures |
Primary outcome
Information understanding and retention
Time frame: One week after intervention
Assessed via a 12-question multiple-choice quiz sent via text message one week after the initial appointment.
7 secondary outcomes
Patient Anxiety Level
Time frame: Baseline; pre-intervention
Patient Anxiety Level
Time frame: On day of surgery
Time and Motion Study
Time frame: On day of surgery
Participant-reported engagement time with the information material
Time frame: One week after intervention
Cancellation rates
Time frame: Within 7 days of surgery
Incidence of incidents and complaints
Time frame: Up to 12 months post-operatively
Patient and clinician satisfaction: Assessed on the surgery day using a 5-point Likert scale Patient and clinician satisfaction
Time frame: On day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 20805130Ali N, Little BC. Causes of cataract surgery malpractice claims in England 1995-2008. Br J Ophthalmol. 2011 Apr;95(4):490-2. doi: 10.1136/bjo.2010.182774. Epub 2010 Aug 30.
- Background: PubMed 28191349Zhang Y, Ruan X, Tang H, Yang W, Xian Z, Lu M. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:9593631. doi: 10.1155/2017/9593631. Epub 2017 Jan 16.
- Background: PubMed 22062774Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012 Jan;38(1):80-4. doi: 10.1016/j.jcrs.2011.07.030. Epub 2011 Nov 6.
- Background: PubMed 31144057Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM. A randomized, controlled trial of video supplementation on the cataract surgery informed consent process. Graefes Arch Clin Exp Ophthalmol. 2019 Aug;257(8):1719-1728. doi: 10.1007/s00417-019-04372-5. Epub 2019 May 30.
- Background: PubMed 37217292Wagner SK, Raja L, Cortina-Borja M, Huemer J, Struyven R, Keane PA, Balaskas K, Sim DA, Thomas PBM, Rahi JS, Solebo AL, Kang S. Determinants of non-attendance at face-to-face and telemedicine ophthalmic consultations. Br J Ophthalmol. 2024 Mar 20;108(4):625-632. doi: 10.1136/bjo-2022-322389.
- Background: PubMed 15286671Bhan A, Dave D, Vernon SA, Bhan K, Bhargava J, Goodwin H; Medical Defence Union; Medical Protection Society; Medical and Dental Defence Union of Scotland. Risk management strategies following analysis of cataract negligence claims. Eye (Lond). 2005 Mar;19(3):264-8. doi: 10.1038/sj.eye.6701493.
- Background: PubMed 22386949Mathew RG, Ferguson V, Hingorani M. Clinical negligence in ophthalmology: fifteen years of national health service litigation authority data. Ophthalmology. 2013 Apr;120(4):859-64. doi: 10.1016/j.ophtha.2012.01.009. Epub 2012 Mar 2.
- Background: PubMed 18096077Ali N. A decade of clinical negligence in ophthalmology. BMC Ophthalmol. 2007 Dec 20;7:20. doi: 10.1186/1471-2415-7-20.
- Background: PubMed 36779806Gill ZS, Caldwell AS, Patnaik JL, Marin AI, Mudie LI, Grove N, Ifantides C, Ertel MK, Puente MA, Seibold LK. Comparison of cataract surgery outcomes in English proficient and limited English proficiency patients. J Cataract Refract Surg. 2023 Jun 1;49(6):595-601. doi: 10.1097/j.jcrs.0000000000001164.
- Background: PubMed 26541685Patel DN, Wakeam E, Genoff M, Mujawar I, Ashley SW, Diamond LC. Preoperative consent for patients with limited English proficiency. J Surg Res. 2016 Feb;200(2):514-22. doi: 10.1016/j.jss.2015.09.033. Epub 2015 Oct 3.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers. This decision is based on concerns about participant privacy and confidentiality, as well as the sensitive nature of the data collected in this study such as patient anxiety levels, and complaints and litigations. Instead, we will disseminate aggregated findings through peer-reviewed publications and presentations, ensuring the protection of participant identities while sharing valuable insights with the scientific community.
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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.
Swan Kang, MBBS, MBioch (Oxon), FRCOphth principal investigator
Moorfields Eye Hospital NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Generated Informative Videos and Standard Written Information Brochures in people with Cataract, run by Moorfields Eye Hospital NHS Foundation Trust at 2 sites in United Kingdom.
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 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 Swan Kang, MBBS, MBioch (Oxon), FRCOphth (07958585904, swan.kang1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information understanding and retention (time frame: One week after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06528509, which also lists 10 linked publications.
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 30 Jul 2024.