Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AG072035-03 | U.S. NIH Grant/Contract | View source |
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Not provided
Not provided
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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The goal of this pilot clinical trial comparing two different sedation approaches for cataract surgery is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, the quality of recovery, and surgical outcomes for the purpose of planning a larger clinical trial. Participants will be asked to respond to several surveys throughout the study on their experience and to assess outcomes of interest.
This is a single-center, randomized, double-blinded, pilot clinical trial (n=20). Participants having first eye cataract surgery will be randomized to receive an oral benzodiazepine (intervention) or an oral placebo pill (control). The primary goal of this study is to assess the feasibility, completeness, and distribution of data in measuring patient satisfaction, quality of recovery, and surgical outcomes in participants receiving oral sedation versus oral placebo for cataract surgery. The secondary goals of this study are to assess success with recruitment, intervention fidelity, adherence to interventions and participant retention after interventions. Participants will be asked to respond to several surveys at key study timepoints regarding their sedation experiences and to assess outcomes of interest.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Oral sedation will be administered to patients prior to the procedure. |
|
| Placebo | Placebo Comparator | An oral placebo pill will be administered to patients prior to the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral sedation | Procedure | Oral medication for anxiolysis administered in the preoperative setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With High Satisfaction (ISAS Score ≥ 2) | The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2. | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Meeting Eligibility Criteria at Screening | Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility | At screening (prior to enrollment) |
| Number of Participants Completing All Study Surveys at Each Timepoint |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine L Chen, M.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25875258 | Background | Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA, Dudley RA. Preoperative medical testing in Medicare patients undergoing cataract surgery. N Engl J Med. 2015 Apr 16;372(16):1530-8. doi: 10.1056/NEJMsa1410846. | |
| 29346472 | Background | Chen CL, Clay TH, McLeod S, Chang HP, Gelb AW, Dudley RA. A Revised Estimate of Costs Associated With Routine Preoperative Testing in Medicare Cataract Patients With a Procedure-Specific Indicator. JAMA Ophthalmol. 2018 Mar 1;136(3):231-238. doi: 10.1001/jamaophthalmol.2017.6372. |
Not provided
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This is a small single center pilot study so we do not plan to make individual participant data available to other researchers.
Not provided
Not provided
Not provided
Not provided
No washout or run-in procedures occurred between enrollment and assignment. After enrollment, participants completed baseline assessments and eligibility confirmation prior to day-of-surgery randomization. Participants who did not proceed to surgery as scheduled or withdrew consent before surgery were not assigned to a study arm.
Recruitment occurred during the study period at UCSF-affiliated outpatient ophthalmology surgical sites. Eligible adults scheduled for elective cataract surgery were identified through surgical schedules and preoperative records. Study staff contacted patients by phone prior to surgery to screen eligibility, describe the study, and obtain informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Oral sedation will be administered to patients prior to the procedure. |
| FG001 | Placebo | An oral placebo pill will be administered to patients prior to the procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Oral sedation will be administered to patients prior to the procedure. |
| BG001 | Placebo | An oral placebo pill will be administered to patients prior to the procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants Meeting Eligibility Criteria at Screening | Number of participants who met all eligibility criteria at the time of screening, out of the total number of participants assessed for eligibility | Posted | Count of Participants | Participants | At screening (prior to enrollment) |
|
from enrollment until end of chart review, up to 30 days after the post-operative visit
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Oral sedation will be administered to patients prior to the procedure. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | General disorders | Systematic Assessment | The event was not related to the study intervention and all reporting was done as specified by the study protocol |
This pilot study was limited by a small sample size and was not powered to detect statistically significant differences between study arms. Recruitment was extended due to external factors and a limited number of participating surgeons with restricted operating days, which constrained enrollment. The study was conducted at a single academic center, limiting generalizability, and some enrolled participants were not randomized due to day-of-surgery external factors, further reducing the sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Chen | University of California, San Francisco | 415-476-0683 | Catherine.Chen@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2025 | May 7, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
A single-center, randomized, double-blinded, randomized pilot clinical trial
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Not provided
Patients, clinicians (operating room nurses, ophthalmologists, and anesthesia staff), and research staff responsible for data collection and analysis will be blinded to the treatment group in order to minimize bias and maximize the validity of results.
| Placebo | Procedure | A placebo pill with no active ingredients administered in the preoperative setting |
|
Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm |
| 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) |
| Number of Participants Who Completed All Required Study Procedures | Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study Instruments: Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI) | From enrollment through final study follow-up (POD7) |
| Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up | Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study | From enrollment through 30 days after surgery |
| Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS) | The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains. For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point. | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) |
| Quality of Recovery-15 (QoR-15) Total Score After Surgery | The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence. Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150. Higher scores indicate better recovery. | 1 day and 7 days after surgery |
| Functional Recovery Index (FRI) Total Score After Surgery | The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living. Each item is scored and summed to produce a total score ranging from 0 to 100. Lower scores indicate better functional recovery. | 1 day and 7 days after surgery |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants Completing All Study Surveys at Each Timepoint | Number of participants who completed all required study surveys at each postoperative timepoint (PACU, POD1, POD7), out of the number of participants assigned to each study arm | Posted | Count of Participants | Participants | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) |
|
|
|
| Secondary | Number of Participants Who Completed All Required Study Procedures | Number of participants who completed all required study procedures from enrollment through the final postoperative follow-up visit, out of the total number of participants enrolled in the study Instruments: Iowa Satisfaction with Anesthesia Scale (ISAS) Postoperative Quality of Recovery Scale (PQRS) Quality of Recovery-15 (QoR-15) Functional Recovery Index (FRI) | Posted | Count of Participants | Participants | From enrollment through final study follow-up (POD7) |
|
|
|
| Secondary | Number of Participants With Sedation-Related Complications During 30-Day Postoperative Follow-up | Number of participants experiencing at least one sedation-related complication within 30 days after surgery, out of the total number of participants enrolled in the study | Posted | Count of Participants | Participants | From enrollment through 30 days after surgery |
|
|
|
| Secondary | Number of Participants Achieving Recovery on the Postoperative Quality of Recovery Scale (PQRS) | The Postoperative Quality of Recovery Scale (PQRS) assesses recovery across physiological, pain, emotional, cognitive, and activities of daily living domains. For this analysis, recovery is defined as meeting PQRS recovery criteria at each time point. Recovery is defined as a return to baseline performance in all assessed PQRS domains at each time point. | Analyses include participants with available PQRS data at each time point. Participants with missing PQRS assessments were excluded from that timepoint-specific analysis. As a result, the number analyzed varies by time point and by study arm. The overall group reflects the total number of participants with available data across both arms at each time point. | Posted | Count of Participants | Participants | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) |
|
|
|
| Secondary | Quality of Recovery-15 (QoR-15) Total Score After Surgery | The Quality of Recovery-15 (QoR-15) is a validated 15-item questionnaire assessing postoperative recovery across physical comfort, emotional state, psychological support, and physical independence. Each item is scored from 0 to 10, and the total score is calculated by summing all items, resulting in a total score range of 0 to 150. Higher scores indicate better recovery. | All patients completed the full survey, however some patients expressed that they felt some questions were not applicable to their post-operative cataract recovery and did not provide a score. We omitted missing data from specific day-of analyses. | Posted | Mean | Standard Deviation | scores on a scale | 1 day and 7 days after surgery |
|
|
|
| Secondary | Functional Recovery Index (FRI) Total Score After Surgery | The Functional Recovery Index (FRI) is a validated 14-item questionnaire assessing postoperative functional recovery, including mobility and activities of daily living. Each item is scored and summed to produce a total score ranging from 0 to 100. Lower scores indicate better functional recovery. | Posted | Mean | Standard Deviation | scores on a scale | 1 day and 7 days after surgery |
|
|
|
| Primary | Number of Participants With High Satisfaction (ISAS Score ≥ 2) | The Iowa Satisfaction with Anesthesia Scale (ISAS) is an 11-item validated questionnaire assessing patient satisfaction with anesthesia care. Each item is scored from -3 to +3, and the total score is calculated as the mean of all items, resulting in a total score range of -3 to +3. Higher scores indicate greater satisfaction. For this analysis, high satisfaction is defined as an ISAS score ≥ 2. | All randomized participants were included in the analysis at each timepoint (N=20). For participants with missing ISAS responses, values were imputed using a permutation-based approach to preserve the overall distribution of observed responses within each study arm. As a result, the number analyzed remains constant across timepoints and matches the number of participants assigned to each arm. | Posted | Count of Participants | Participants | 30 minutes (PACU), 1 day (POD1), and 7 days after surgery (POD7) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Placebo | An oral placebo pill will be administered to patients prior to the procedure. | 0 | 10 | 0 | 10 | 1 | 10 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment | These events were categorized by their relationship to the study intervention, severity, start and stop date, and classified by involvement with the study. |
|
| Emergency Room Visit | Renal and urinary disorders | Systematic Assessment | The event was not related to the study intervention, and all reporting was done as specified by the study protocol. The event was not serious, occurring within the follow-up window, but was not related to the study. |
|
Not provided
Not provided
| D001519 |
| Behavior |
| POD7 |
|
| FRI |
|
| QoR-15 |
|
| POD1 |
|
|
| POD7 |
|
|
| POD7 |
|
|
|
| Title | Measurements |
|---|---|
|
| POD7 |
|