AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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 groups in NCT07038395
Study groupRoleWhat they receive
Nonsterile feeder room modelProcedures performed in a separate room from the operating room
Receives: Device: workflow
Sterile room modelProcedures 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.

  1. 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

  2. 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

  3. 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.

  1. First posted26 Jun 2025
  2. Study start9 Jun 2023
  3. Primary completion17 May 2024
  4. Study completion29 Jun 2024

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in