CataractNCT07544641
Effect of Surgical Planning Prompts on Elective Surgery Acceptance Rate
A study testing Structured Surgical Planning Self-Reflection in people with Cataract, run by Tongji University.
Trial summary
This randomized, double-blind, controlled trial investigates whether prompting patients facing elective cataract surgery to articulate their specific conditions for choosing surgery (a structured self-reflection intervention commonly used in Shared Decision-Making) affects their subsequent decision to undergo the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Structured Surgical Planning Self-Reflection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2026to Apr 2027
- 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
- 1. Diagnosed with one of the following: age-related cataract, complicated cataract, traumatic cataract, metabolic cataract, or congenital cataract 2. Age 18+ years 3. Baseline intraocular pressure (IOP) ≤ 21 mmHg 4. Axial length 20-30 mm 5. No intraocular surgery within the past 3 months 6. Meets at least ONE of the following functional criteria:
- Best Corrected Visual Acuity (BCVA) ≤ 0.5 and vision loss primarily attributable to cataract
- Posterior subcapsular cataract with patient-reported significant impact from glare, halos, or impaired night driving
- Patient-reported significant decrease in contrast sensitivity
- Anisometropia or refractive error, and patient reports inability to accept spectacle correction impacting reading, daily chores, TV viewing, driving, or outdoor activities
- Cataract interfering with fundus examination/treatment (e.g., diabetic retinopathy, macular disease, uveitis)
- Lens with risk of inducing glaucoma (shallow anterior chamber with family history or fellow-eye history of angle-closure, lens dislocation/subluxation, hypermature cataract)
Who cannot join
- Already decided to undergo or decline surgery at time of initial consultation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Patient Surgical Planning on Elective Surgery Acceptance Rate: A Randomized Controlled Trial
This randomized, double-blind, controlled trial investigates whether prompting patients facing elective cataract surgery to articulate their specific conditions for choosing surgery (a structured self-reflection intervention commonly used in Shared Decision-Making) affects their subsequent decision to undergo the procedure. Eligible cataract patients who have been informed of surgical indications at an outpatient visit will be randomly assigned 1:1 to an intervention group (structured writing about personal conditions for accepting surgery) or a control group (no writing task). Both groups read the same standardized information about cataract diagnosis and treatment, and both complete the same set of follow-up questionnaire items. Three treating physicians independently rate their degree of surgical recommendation for each patient; these ratings along with baseline clinical measures are included as covariates in the analysis. The primary outcome is whether participants register for cataract surgery within 6 months of their initial outpatient consultation. Secondary outcomes include self-reported understanding of the condition, clarity of treatment plan, condition-related anxiety, perceived urgency, perceived helpfulness of the consultation, semantic analysis of written responses, and patient experience measures.
Read the detailed description
Shared Decision-Making (SDM) tools for elective surgery often include exercises that ask patients to clarify under what conditions they would choose surgery. While such prompts have been effective for promoting medication adherence and vaccination, elective surgery is a higher-stakes decision involving pain, recovery, and cost concerns. A preliminary study of 60 patients found that 16.7% of controls versus 0% of intervention participants registered for surgery within 4 months, raising the hypothesis that structured self-reflection may inadvertently reduce surgical uptake by heightening patients' concerns.
Both groups first read a standardized paragraph explaining their cataract diagnosis and the availability of phacoemulsification surgery. The intervention group then receives a structured prompt asking them to write in detail about the specific conditions under which they would feel confident choosing surgery (e.g., "When I can confirm post-operative care from family for 3 days, I would be willing to proceed"). The control group does not receive a writing task and proceeds directly to the follow-up questionnaire items, which are identical across groups.
Three treating physicians each recruit from their own outpatient clinics within the same hospital. Each physician provides standardized, non-directive explanations of the condition and treatment options, and independently rates their degree of surgical recommendation for each of their patients based on their clinical judgment of surgical appropriateness. These physician recommendation ratings are included as covariates in the analysis. Baseline ophthalmic clinical measures - including visual acuity, best corrected visual acuity (BCVA), presence of fundus pathology or other ocular comorbidities, BCVA of the contralateral eye, cataract type and grade, and intraocular pressure - are also recorded and may be included as covariates.
After questionnaire completion, research assistants will track whether each participant registers for surgery within 6 months. Following surgery or the 6-month endpoint (whichever is earlier), participants will be fully debriefed and asked for informed consent. Data from participants who decline consent will be destroyed.
- Conditions
- Cataract
- Being tested
- Structured Surgical Planning Self-Reflection
- Keywords
- Cataract, Shared Decision-Making, Elective Surgery, Surgical Planning, Decision Aid, Patient Autonomy, Behavioral Intervention
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Surgical Planning Self-ReflectionBehavioural
Participants are guided through an online structured writing exercise that prompts them to articulate the specific personal conditions under which they would choose to undergo elective cataract surgery. The prompt is embedded within an online questionnaire presented under the cover story of a comprehensive clinical assessment. It asks participants to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept the surgery, considering factors such as physical readiness, work, family, finances, timing, etc.
| Study group | Role | What they receive |
|---|---|---|
| Structured Self-Reflection (Intervention) | Experimental | Participants receive a structured prompt via an online questionnaire asking them to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept elective cataract surgery. For example: "When I can confirm that my children will be available for 3 days post-surgery, I would be willing to undergo the operation." This intervention guides participants to actively define a personal pathway toward the surgical decision Receives: Behavioral: Structured Surgical Planning Self-Reflection |
| No Writing Task (Control) | No intervention | After reading the same standardized introductory paragraph about cataract diagnosis and treatment as the intervention group, control participants proceed directly to the follow-up questionnaire items without any writing task. All subsequent questionnaire items are identical to those completed by the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Registration Within 6 Months
Proportion of participants who register (sign up) for cataract surgery at the Shanghai General Hospital Ophthalmology Clinical Center within 6 months of their initial outpatient consultation at which they were informed of surgical indications. Determined by cross-referencing surgery registration lists with study participant records.
Measured: 6 months from initial outpatient consultation
Secondary outcomes (6)
Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much)
Patient-reported level of understanding of their cataract condition following the outpatient consultation, measured via a single-item self-assessment in the online questionnaire.
Measured: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Clarity of Treatment Plan (3-point scale, 1 = not at all, 3 = very much)
Patient-reported sense of having a clear plan regarding subsequent treatment for their eye condition, measured via a single-item self-assessment.
Measured: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Condition-Related Anxiety (3-point scale, 1 = not at all, 3 = very much)
Patient-reported level of anxiety about their current cataract condition, measured via a single-item self-assessment.
Measured: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Perceived Urgency to Act (3-point scale, 1 = not at all, 3 = very much)
Patient-reported perceived urgency of taking the next step for their cataract condition, measured via a single-item self-assessment.
Measured: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Perceived Helpfulness of Consultation (3-point scale, 1 = not at all, 3 = very much)
Patient-reported overall assessment of how helpful the outpatient visit was, measured via a single-item self-assessment.
Measured: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Semantic Content Analysis of Written Responses
Qualitative and quantitative analysis of the text written by intervention-group participants in the structured self-reflection task, examining themes, specificity, emotional valence, and their correlation with surgical uptake.
Measured: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Zhang, PhD, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544641
- Sponsor's protocol ID
- elective surgery cataract
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all the primary, secondery, and other outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Surgical Planning on Elective Surgery Acceptance Rate: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07544641
- Acronym / sponsor ID
- elective surgery cataract
- Conditions
- Cataract
- Keywords
- Cataract, Shared Decision-Making, Elective Surgery, Surgical Planning, Decision Aid, Patient Autonomy, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Apr 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.
This randomized, double-blind, controlled trial investigates whether prompting patients facing elective cataract surgery to articulate their specific conditions for choosing surgery (a structured self-reflection intervention commonly used in Shared Decision-Making) affects their subsequent decision to undergo the procedure. Eligible cataract patients who have been informed of surgical indications at an outpatient visit will be randomly assigned 1:1 to an intervention group (structured writing about personal conditions for accepting surgery) or a control group (no writing task). Both groups read the same standardized information about cataract diagnosis and treatment, and both complete the same set of follow-up questionnaire items. Three treating physicians independently rate their degree of surgical recommendation for each patient; these ratings along with baseline clinical measures are included as covariates in the analysis. The primary outcome is whether participants register for cataract surgery within 6 months of their initial outpatient consultation. Secondary outcomes include self-reported understanding of the condition, clarity of treatment plan, condition-related anxiety, perceived urgency, perceived helpfulness of the consultation, semantic analysis of written responses, and patient experience measures.
Detailed description
Shared Decision-Making (SDM) tools for elective surgery often include exercises that ask patients to clarify under what conditions they would choose surgery. While such prompts have been effective for promoting medication adherence and vaccination, elective surgery is a higher-stakes decision involving pain, recovery, and cost concerns. A preliminary study of 60 patients found that 16.7% of controls versus 0% of intervention participants registered for surgery within 4 months, raising the hypothesis that structured self-reflection may inadvertently reduce surgical uptake by heightening patients' concerns.
Both groups first read a standardized paragraph explaining their cataract diagnosis and the availability of phacoemulsification surgery. The intervention group then receives a structured prompt asking them to write in detail about the specific conditions under which they would feel confident choosing surgery (e.g., "When I can confirm post-operative care from family for 3 days, I would be willing to proceed"). The control group does not receive a writing task and proceeds directly to the follow-up questionnaire items, which are identical across groups.
Three treating physicians each recruit from their own outpatient clinics within the same hospital. Each physician provides standardized, non-directive explanations of the condition and treatment options, and independently rates their degree of surgical recommendation for each of their patients based on their clinical judgment of surgical appropriateness. These physician recommendation ratings are included as covariates in the analysis. Baseline ophthalmic clinical measures - including visual acuity, best corrected visual acuity (BCVA), presence of fundus pathology or other ocular comorbidities, BCVA of the contralateral eye, cataract type and grade, and intraocular pressure - are also recorded and may be included as covariates.
After questionnaire completion, research assistants will track whether each participant registers for surgery within 6 months. Following surgery or the 6-month endpoint (whichever is earlier), participants will be fully debriefed and asked for informed consent. Data from participants who decline consent will be destroyed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Self-Reflection (Intervention) | Experimental | Behavioral: Structured Surgical Planning Self-ReflectionParticipants receive a structured prompt via an online questionnaire asking them to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept elective cataract surgery. For example: "When I can confirm that my children will be available for 3 days post-surgery, I would be willing to undergo the operation." This intervention guides participants to actively define a personal pathway toward the surgical decision |
| No Writing Task (Control) | No intervention | –After reading the same standardized introductory paragraph about cataract diagnosis and treatment as the intervention group, control participants proceed directly to the follow-up questionnaire items without any writing task. All subsequent questionnaire items are identical to those completed by the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Diagnosed with one of the following: age-related cataract, complicated cataract, traumatic cataract, metabolic cataract, or congenital cataract 2. Age 18+ years 3. Baseline intraocular pressure (IOP) ≤ 21 mmHg 4. Axial length 20-30 mm 5. No intraocular surgery within the past 3 months 6. Meets at least ONE of the following functional criteria:
Key exclusion criteria (1 listed)
- Already decided to undergo or decline surgery at time of initial consultation
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 |
|---|---|---|
| Structured Surgical Planning Self-ReflectionParticipants are guided through an online structured writing exercise that prompts them to articulate the specific personal conditions under which they would choose to undergo elective cataract surgery. The prompt is embedded within an online questionnaire presented under the cover story of a comprehensive clinical assessment. It asks participants to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept the surgery, considering factors such as physical readiness, work, family, finances, timing, etc. | Behavioural | Structured Self-Reflection (Intervention) |
Primary outcome
Rate of Surgical Registration Within 6 Months
Time frame: 6 months from initial outpatient consultation
Proportion of participants who register (sign up) for cataract surgery at the Shanghai General Hospital Ophthalmology Clinical Center within 6 months of their initial outpatient consultation at which they were informed of surgical indications. Determined by cross-referencing surgery registration lists with study participant records.
6 secondary outcomes
Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much)
Time frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Clarity of Treatment Plan (3-point scale, 1 = not at all, 3 = very much)
Time frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Condition-Related Anxiety (3-point scale, 1 = not at all, 3 = very much)
Time frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Perceived Urgency to Act (3-point scale, 1 = not at all, 3 = very much)
Time frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Perceived Helpfulness of Consultation (3-point scale, 1 = not at all, 3 = very much)
Time frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
Semantic Content Analysis of Written Responses
Time frame: At time of questionnaire completion (Within 48 hours post-initial outpatient consultation)
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 22 Apr 2026.
- Individual participant dataSharing planned: Yes. all the primary, secondery, and other outcome measures.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Surgical Planning Self-Reflection in people with Cataract, run by Tongji University.
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 7 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Y. Charles Zhang (+86 13262886498, yizi@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Surgical Registration Within 6 Months (time frame: 6 months from initial outpatient consultation). 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 22 Apr 2026.