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

NCT03931629 | Completed DMC FDA Device

• 1 other identifier: FLACS
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Cataract Mature; Cataract, Nuclear

Keywords

FEMTOSECOND LASER; Femtosecond Laser-Assisted Cataract Surgery; CATARACT SURGERY; phacoemulsification; operation room workflow; public setting

Outcome Measures

Primary Outcomes (1)

• WORKFLOW IN THE OPERATION ROOM (minutes)

  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.

  Operation day

Secondary Outcomes (2)

• CUMULATIVE DISSIPATED ENERGY (MEASUREN IN %, PROVIDED BY THE PHACOEMULSIFICATION DEVICE)

  Operation day

• INTRAOPERATIVE COMPLICATIONS

  Operation day

Study Arms (2)

CONVENTIONAL PHACO

ACTIVE COMPARATOR

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

FEMTOSECONDLASER (FLACS)

ACTIVE COMPARATOR

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

Interventions

CONVENTIONAL PHACO PROCEDURE

Cataract surgery by means of Femtosecond Laser-Assisted Cataract Surgery,

Also known as: FEMTOSECONDLASER (FLACS)

CONVENTIONAL PHACO; FEMTOSECONDLASER (FLACS)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Related Publications (1)

• Villavilla-Castillo J, Perez-Casaseca C, Espejo-de-Los-Riscos E, Fernandez-Baca-Vaca G, Fernandez-Baca-Casares I, Pinero-Llorens DP, Rocha-de-Lossada C, Rodriguez-Calvo-de-Mora M. Study of the efficiency and workflow of femtosecond laser-assisted cataract surgery in a Spanish public hospital. J Fr Ophtalmol. 2021 Oct;44(8):1190-1201. doi: 10.1016/j.jfo.2021.01.030. Epub 2021 Jul 16.

  PMID: 34275664 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: NO MASKING
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 30, 2019
• Study Start: January 1, 2016
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: April 30, 2019

Record last verified: 2019-03