CataractNCT07038395
Retrospective Analysis of the Time Elements for Different Workflow Scenarios During Femtosecond Laser-assisted Cataract Surgery (FLACS) From the Surgeon, Staff, and Patient Perspectives.
An observational study of Cataract, run by LensAR Incorporated at 1 site in United States.
Trial summary
This study involves the retrospecitve review of time stamps during surgery to assess the time efficiencies of different workflow scenarios of femtosecond laser-assisted cataract surgery from the surgeon, staff, and patient perspectives. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- workflow
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 29 Jun 2024
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who have undergone previous cataract surgery and meet the inclusion and exclusion criteria
Who may be able to join
- Subject (male or female) must be at least 21 years of age
- Subject must have had an operable cataract in the study eye
- Eligible for femtosecond laser treatment and phacoemulsification
- Subject elected to undergo cataract extraction
Who cannot join
- Subjects who have difficulty lying flat for a 1-hour time period (e.g., spinal stenosis, cervical neck injury, claustrophobia, anxiety disorder, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
North Georgia Eye Associates
Gainesville, Georgia, 30501
About this study
Official title: Retrospective Comparative Analysis of Time and Motion Workflow of Femtosecond Laser-assisted Cataract Surgery (FLACS) in Multiple Surgical Settings
This study involves the retrospecitve review of time stamps during surgery to assess the time efficiencies of different workflow scenarios of femtosecond laser-assisted cataract surgery from the surgeon, staff, and patient perspectives.
Objectives are to identify surgical workflows that may increase surgical efficiency and improve patient, surgeon, and staff satisfaction.
Read the detailed description
Cataracts are the most common cause of preventable visual impairment. In the United States, the number of people with cataracts is forecasted to double from 24.4 million to about 50 million by the year 20501. By age 80, half of all Americans have a cataract. Recent and ongoing reductions in reimbursement for cataract surgery have fueled an increased need to drive innovation in ways to be more financially efficient. Simultaneously, new technology in the field, especially as it relates to use of the femtosecond laser for portions of lens surgery, can increase challenges in creating an efficient and cost-effective structure for providing care2.
Understanding operating room workflows is crucial for cataract surgeons, as it allows them to improve efficiency, achieve time savings, and realize significant cost savings. By optimizing workflows, surgeons can streamline processes, reduce delays, and expedite surgical procedures, leading to shorter wait times for patients. Moreover, efficient resource utilization, including surgical instruments and equipment, minimizes waste and reduces unnecessary expenses. This not only enhances surgeon, staff, and patient safety and satisfaction but also maximizes the utilization of operating room facilities, ultimately resulting in cost-effective care delivery3,4.
The introduction of femtosecond laser technology in cataract surgery offers promising advancements and precision in lens procedures. However, integrating this technology into existing workflows presents challenges in creating an efficient and cost-effective care structure. The incorporation of femtosecond laser requires careful evaluation and optimization of workflows to accommodate the added steps and equipment. By understanding the specific requirements and sequencing of tasks, surgeons can identify potential bottlenecks and implement changes that enhance efficiency and minimize disruption in the surgical process. Additionally, evaluating the cost-effectiveness of femtosecond laser usage, considering factors such as equipment costs, maintenance, and potential savings in overall patient care, is crucial for informed decision-making5-8.
Efficiency and cost-effectiveness are essential considerations in cataract surgery, given the increasing prevalence of cataracts and reductions in reimbursement rates. Understanding operating room workflows allows cataract surgeons to optimize processes, reduce delays, and achieve significant cost savings. Moreover, the integration of femtosecond laser technology in lens surgery necessitates careful evaluation and adaptation of workflows to ensure efficient utilization and seamless integration. By prioritizing efficiency, time savings, and cost reduction through workflow optimization and the adoption of innovative technologies, cataract surgeons can provide optimal patient care while addressing the challenges posed by evolving healthcare demands and financial constraints.
The objective of this study is to identify workflows that enhance surgical efficiency and enhance satisfaction among patients, surgeons, and staff by closely monitoring the timing and movements of patients, staff, and surgeons throughout their surgical journey. By analyzing the collected data, workflow efficiencies and best practices to optimize the surgical process can be identified.
- Conditions
- Cataract
- Being tested
- workflow
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
workflowDevice
Placement of the surgical device and its effect on workflow
| Study group | Role | What they receive |
|---|---|---|
| Nonsterile feeder room model | Procedures performed in a separate room from the operating room Receives: Device: workflow | |
| Sterile room model | Procedures performed in a sterile environment Receives: Device: workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the amount of time in seconds required to perform surgical actions relevant to the FLACS procedure
Total seconds required for each step of the surgical procedure
Measured: On day of surgery (Day 0), from beginning to end of surgical procedure
Measurement of time in seconds that a patient is interacting with the surgical staff
Time in seconds from arrival in pre-op area to discharge from post-op area
Measured: On day of surgery, (Day 0), time in seconds from arrival in pre-op area to discharge from post-op area
Amount of time in seconds required to prepare patient for surgery
Amount of time in seconds that patient is present with surgical staff prior to surgical procedure
Measured: On day of surgery, (Day 0), from beginning of patient interaction with staff until surgical procedure begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start9 Jun 2023
- Primary completion17 May 2024
- Study completion29 Jun 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- LensAR Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038395
- Sponsor's protocol ID
- ME-00008-PRO
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Comparative Analysis of Time and Motion Workflow of Femtosecond Laser-assisted Cataract Surgery (FLACS) in Multiple Surgical Settings
- ClinicalTrials.gov ID
- NCT07038395
- Acronym / sponsor ID
- ME-00008-PRO
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- LensAR IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 26 Jun 2025 (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 study involves the retrospecitve review of time stamps during surgery to assess the time efficiencies of different workflow scenarios of femtosecond laser-assisted cataract surgery from the surgeon, staff, and patient perspectives.
Objectives are to identify surgical workflows that may increase surgical efficiency and improve patient, surgeon, and staff satisfaction.
Detailed description
Cataracts are the most common cause of preventable visual impairment. In the United States, the number of people with cataracts is forecasted to double from 24.4 million to about 50 million by the year 20501. By age 80, half of all Americans have a cataract. Recent and ongoing reductions in reimbursement for cataract surgery have fueled an increased need to drive innovation in ways to be more financially efficient. Simultaneously, new technology in the field, especially as it relates to use of the femtosecond laser for portions of lens surgery, can increase challenges in creating an efficient and cost-effective structure for providing care2.
Understanding operating room workflows is crucial for cataract surgeons, as it allows them to improve efficiency, achieve time savings, and realize significant cost savings. By optimizing workflows, surgeons can streamline processes, reduce delays, and expedite surgical procedures, leading to shorter wait times for patients. Moreover, efficient resource utilization, including surgical instruments and equipment, minimizes waste and reduces unnecessary expenses. This not only enhances surgeon, staff, and patient safety and satisfaction but also maximizes the utilization of operating room facilities, ultimately resulting in cost-effective care delivery3,4.
The introduction of femtosecond laser technology in cataract surgery offers promising advancements and precision in lens procedures. However, integrating this technology into existing workflows presents challenges in creating an efficient and cost-effective care structure. The incorporation of femtosecond laser requires careful evaluation and optimization of workflows to accommodate the added steps and equipment. By understanding the specific requirements and sequencing of tasks, surgeons can identify potential bottlenecks and implement changes that enhance efficiency and minimize disruption in the surgical process. Additionally, evaluating the cost-effectiveness of femtosecond laser usage, considering factors such as equipment costs, maintenance, and potential savings in overall patient care, is crucial for informed decision-making5-8.
Efficiency and cost-effectiveness are essential considerations in cataract surgery, given the increasing prevalence of cataracts and reductions in reimbursement rates. Understanding operating room workflows allows cataract surgeons to optimize processes, reduce delays, and achieve significant cost savings. Moreover, the integration of femtosecond laser technology in lens surgery necessitates careful evaluation and adaptation of workflows to ensure efficient utilization and seamless integration. By prioritizing efficiency, time savings, and cost reduction through workflow optimization and the adoption of innovative technologies, cataract surgeons can provide optimal patient care while addressing the challenges posed by evolving healthcare demands and financial constraints.
The objective of this study is to identify workflows that enhance surgical efficiency and enhance satisfaction among patients, surgeons, and staff by closely monitoring the timing and movements of patients, staff, and surgeons throughout their surgical journey. By analyzing the collected data, workflow efficiencies and best practices to optimize the surgical process can be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonsterile feeder room model | – | Device: workflowProcedures performed in a separate room from the operating room |
| Sterile room model | – | Device: workflowProcedures performed in a sterile environment |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone previous cataract surgery and meet the inclusion and exclusion criteria
Key inclusion criteria (4 listed)
- Subject (male or female) must be at least 21 years of age
- Subject must have had an operable cataract in the study eye
- Eligible for femtosecond laser treatment and phacoemulsification
- Subject elected to undergo cataract extraction
Key exclusion criteria (1 listed)
- Subjects who have difficulty lying flat for a 1-hour time period (e.g., spinal stenosis, cervical neck injury, claustrophobia, anxiety disorder, etc.).
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 |
|---|---|---|
| workflowPlacement of the surgical device and its effect on workflow | Device | Nonsterile feeder room model, Sterile room model |
Primary outcome
Identification of the amount of time in seconds required to perform surgical actions relevant to the FLACS procedure
Time frame: On day of surgery (Day 0), from beginning to end of surgical procedure
Total seconds required for each step of the surgical procedure
Measurement of time in seconds that a patient is interacting with the surgical staff
Time frame: On day of surgery, (Day 0), time in seconds from arrival in pre-op area to discharge from post-op area
Time in seconds from arrival in pre-op area to discharge from post-op area
Amount of time in seconds required to prepare patient for surgery
Time frame: On day of surgery, (Day 0), from beginning of patient interaction with staff until surgical procedure begins
Amount of time in seconds that patient is present with surgical staff prior to surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by LensAR Incorporated 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 4 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: finished, as of the sponsor's last update on 26 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of the amount of time in seconds required to perform surgical actions relevant to the FLACS procedure (time frame: On day of surgery (Day 0), from beginning to end of surgical procedure). The study lists 3 primary outcomes in all. 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 26 Jun 2025.