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Study of the Efficiency and Workflow of Femtosecond Laser Assisted Cataract Surgery in a Spanish Public Hospital (FLACS)

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ClinicalTrials.gov Identifier: NCT03931629
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary:

Purpose: To assess the time-efficiency of a designated operation room (OR) workflow in the introduction of Femtosecond laser-assisted cataract surgery (FLACS, LenSx, Alcon®). The study was carried out in a public hospital with high volume of procedures.

Setting: Ophthalmology department of a tertiary referral Spanish public hospital.

Design: Prospective, controlled, surgical intervention study. Methods: A total of 167 eyes were enrolled, including 62 eyes undergoing conventional phacoemulsification surgery. In phase I, patients were assigned either to FLACS-I (n=63) or conventional phacoemulsification surgery (n=62). One surgeon operated the Femto-second laser, another finished the procedure, whereas another performed a conventional phacoemulsification. In the second phase (FLACS-II), all the surgeries were FLACS (n=42). A surgeon performed the FLACS procedure and two different surgeons completed the surgeries in separated ORs. Surgical and roll-over times of all the patients were recorded.


Condition or disease Intervention/treatment Phase
Cataract Cataract Mature Cataract, Nuclear Procedure: CONVENTIONAL PHACO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study design. This study was composed of two phases and was carried out by three consultant surgeons. No resident or trainee was involved in the performance of the surgeries. In Phase I, one of the three surgeons operated the LensX®, another performed the FLACS surgery (FLACS I) in one operating room (OR1), while the third surgeon performed the conventional phacoemulsification procedure (MANUAL) in another operating room (OR2). On subsequent days, the surgeons rotated between LensX®, FLACS and MANUAL surgery (Figure 1). All the settings for the Infiniti® and the LensX® were the same for all surgeons (see below). The cataracts included in the FLACS I group were presumably straightforward, as they were part of the learning curve for the surgeons and were evaluated by consultant ophthalmologists (it must be considered that the maximum best-corrected visual acuity [BCVA] for being eligible for cataract surgery in the Andalusian public System is 0.4 logMAR).
Masking: None (Open Label)
Masking Description: NO MASKING
Primary Purpose: Treatment
Official Title: Study of the Efficiency and Workflow of Femtosecond Laser Assisted Cataract Surgery in a Spanish Public Hospital
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CONVENTIONAL PHACO
In Phase I, one of the three surgeons operated the LensX®, another performed the FLACS surgery (FLACS I) in one operating room (OR1), while the third surgeon performed the conventional phacoemulsification procedure (MANUAL) in another operating room (OR2). On subsequent days, the surgeons rotated between LensX®, FLACS and MANUAL surgery
Procedure: CONVENTIONAL PHACO
Cataract surgery by means of Femtosecond Laser-Assisted Cataract Surgery,
Other Name: FEMTOSECONDLASER (FLACS)

Active Comparator: FEMTOSECONDLASER (FLACS)
In Phase I, one of the three surgeons operated the LensX®, another performed the FLACS surgery (FLACS I) in one operating room (OR1), while the third surgeon performed the conventional phacoemulsification procedure (MANUAL) in another operating room (OR2). On subsequent days, the surgeons rotated between LensX®, FLACS and MANUAL surgery
Procedure: CONVENTIONAL PHACO
Cataract surgery by means of Femtosecond Laser-Assisted Cataract Surgery,
Other Name: FEMTOSECONDLASER (FLACS)




Primary Outcome Measures :
  1. WORKFLOW IN THE OPERATION ROOM (minutes) [ Time Frame: Operation day ]
    Surgical and roll-over times (measured in minutes) for both conventional phacoemulsification and FLACS were assessed: start time of patient preparation, anesthesia and surgery, surgery end time, time needed to transfer the patient to resting area, and time of discharge; time from the insertion of blepharostat to its removal after ending the surgical procedure, time from the moment the patient entered the OR to the moment the patient left the OR after finishing the surgery, and time from the admission of the patient to the surgical area to the discharge once the intervention was finished.


Secondary Outcome Measures :
  1. CUMULATIVE DISSIPATED ENERGY (MEASUREN IN %, PROVIDED BY THE PHACOEMULSIFICATION DEVICE) [ Time Frame: Operation day ]
    Likewise, mean phacoemulsification energy values (measured in %, as provided bu the phacoemulsification device) used in each procedure was also recorded (CDE: cumulative dissipated energy).

  2. INTRAOPERATIVE COMPLICATIONS [ Time Frame: Operation day ]
    Intraoperative complications were also recorded, including loss of suction, loss of fixation/follow-up and incomplete capsulorrhexis for the femtosecond laser-assisted stage, and incomplete rexis, capsular rupture, IOL dislocation and incisions without coaptation for the phacoemulsification stage.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signing.
  • Over 18 years old.
  • No medical contraindication for cataract surgery.
  • Maximum best-corrected visual acuity [BCVA] 0.4 logMAR.
  • Patients with easily accessible sockets.
  • Minimal pupil mydriasis of 6 mm.
  • Anticipated good patient collaboration.

Exclusion Criteria:

  • No informed consent signing.
  • Patients under 18 years old.
  • Medical contraindication for cataract surgery.
  • Maximum best-corrected visual acuity [BCVA] over 0.4 logMAR.
  • Patients with badly accessible sockets.
  • Maximal mydriasis inferior to 6 mm.
  • Poor patient collaboration were included.
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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03931629    
Other Study ID Numbers: FLACS
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
FEMTOSECOND LASER
Femtosecond Laser-Assisted Cataract Surgery
CATARACT SURGERY
phacoemulsification
operation room workflow
public setting
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases