Retrospective Analysis of the Time Elements for Different Workflow Scenarios During Femtosecond Laser-assisted Cataract Surgery (FLACS) From the Surgeon, Staff, and Patient Perspectives.

NCT07038395 | Completed FDA Device

• 1 other identifier: ME-00008-PRO
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. Objectives are to identify surgical workflows that may increase surgical efficiency and improve patient, surgeon, and staff satisfaction.

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  On day of surgery, (Day 0), from beginning of patient interaction with staff until surgical procedure begins

Study Arms (2)

Nonsterile feeder room model

Procedures performed in a separate room from the operating room

Device: workflow

Sterile room model

Procedures performed in a sterile environment

Device: workflow

Interventions

workflow DEVICE

Placement of the surgical device and its effect on workflow

Nonsterile feeder room model; Sterile room model

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who have undergone previous cataract surgery and meet the inclusion and exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• Subjects who have difficulty lying flat for a 1-hour time period (e.g., spinal stenosis, cervical neck injury, claustrophobia, anxiety disorder, etc.).

Sponsors & Collaborators

• LensAR Incorporated: lead

Study Sites (1)

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 26, 2025
• Study Start: June 9, 2023
• Primary Completion: May 17, 2024
• Study Completion: June 29, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

US (1)