Study of the Efficiency and Workflow of Femtosecond Laser Assisted Cataract Surgery in a Spanish Public Hospital
Condition: Cataract; Cataract Mature; Cataract, Nuclear
MeSH terms: Cataract
Study type: Interventional

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.
    

Detailed description: 
      MATERIALS AND METHODS Patient recruitment. This single-center, prospective, consecutive,
      interventional, and non-randomized study was conducted at the Department of Ophthalmology of
      the Regional University Hospital of Málaga (Spain) from February to June 2016. Patients were
      recruited in this clinical setting during routine activity. Inclusion criteria for the study
      were signed informed consent, patients of more than 18 years old, presence of visually
      significant cataract (best corrected visual acuity worse than 0.4 logMAR), and possibility of
      performing cataract surgery under local anaesthesia (topical, sub-tenon or retrobulbar).
      Exclusion criteria were patients who refused to give their consent, traumatic, congenital,
      luxated, subluxated cataracts, or with manifest zonular weakness, vitrectomized patients,
      small pupils (mydriasis less than 6 mm), narrow palpebral fissure, advanced optic nerve
      glaucomatous excavation, irregular astigmatism, significant corneal opacities, severe ocular
      surface disease, keratoconus, stromal scarring or edema and patients requiring general
      anaesthesia for the intervention. Patients who complied with the inclusion and exclusion
      criteria mentioned above signed a specific informed consent for the study and were
      non-randomly assigned to the FLACS (femtosecond laser-assisted cataract surgery) or MANUAL
      (manual or conventional phacoemulsification surgery) group. We checked that both groups were
      comparable in terms of age and gender. The three surgeons involved in the study were highly
      experienced consultants in performing conventional cataract surgery (from 15 to 20 years of
      experience, performing from 500 to 800 phacoemulsifications yearly) and refractive surgery
      (10 to 15 years of experience, performing from 200 to 500 refractive procedures). This study
      has been carried out following the Declaration of Helsinki and Good Clinical Practices
      guidelines. Personal data was processed according to guidelines established by the Spanish
      Law of Data Protection (LOPD).

      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). Patients with easily
      accessible sockets and good patient collaboration were included. Eligible cataracts ranged
      from nuclear opacities from NC1 to NC4, cortical opacities from C1 to C4 and posterior
      subcapsular from P1 to P4, according to the Lens Opacities Classifications System (LOCSIII);
      with good pupil dilation (minimum 8 mm, that was measured in the slit lamp as described by Ho
      et al29) after the standard dilation protocol, i.e., instillation of tropicamide 1% and
      fenylephrine 10% eye-drops in the conjunctival sac, three times, each time separated by 10
      minutes. Fuchs endothelial dystrophy and white cataracts were excluded. To ensure the
      comparability among groups, cataracts included in the MANUAL group were selected with similar
      characteristics. In phase II, one of the three surgeons operated the LensX®, while the other
      two surgeons completed the procedures in two different ORs (FLACS II)(Figure 2). Surgeons
      rotated in subsequent days. The FLACS II group included patients with harder cataracts
      (nuclear opacities from NC4 to NC6, cortical opacities from C3 to C5 and posterior
      subcapsular from P3 to P5, according to the LOCSIII), smaller orbits, suboptimal mydriasis
      (from 6 to 8 mm, measured in the slit lamp as mentioned before), Fuchs endothelial dystrophy
      and white cataracts. (Images 1-3). Therefore, this group included the whole range of cataract
      surgeries that are commonly performed at a public hospital.

      Procedures. Prior to surgery, the routine dilation protocol (instillation of tropicamide 1%
      and fenylephrine 10% eye-drops in the conjunctival sac, three times, each time separated by
      10 minutes), preoperative disinfection (cleaning of eyelid and periorbital region with 10%
      povidone iodine and instillation of povidone iodine 5% in in the conjunctival sac) and
      placement of sterile dressing were performed as usual. Conventional phacoemulsification was
      performed using the divide-and-conquer technique through a 2.2-mm clear corneal incision and
      the platform Infiniti® (Alcon®, Fort Worth, Texas, USA). FLACS was performed using the LenSx®
      platform (Alcon® Fort Worth, Texas, USA). The femtosecond laser was placed in a room adjacent
      to the OR, complying with current sterility standards mentioned above. Patients were
      transported from the laser room to the OR in an ophthalmological surgical chair. After
      completing the laser-assisted procedures (capsulorrhexis, nucleus fragmentation, main and
      accessory incisions), the patient entered to the OR where the phacoemulsification and
      aspiration of the nucleus and cortical masses, implantation of the IOL (AcrySof® IQ Monofocal
      IOL, Alcon, Fort Worth, Texas, USA), and hydration of surgical borders were performed. The
      ophthalmic viscosurgical device used in all cases was DuoVisc® Alcon, Fort Worth, Texas,
      USA). Prophylactic 0.1 mL of cefuroxime (1 mg/0.1 mL) was injected in the anterior chamber at
      the end of the surgery. The postoperative follow-up was performed according to usual
      protocols.

      Settings. All the settings for the Infiniti® and the LensX® were the same for all surgeons.
      The Infiniti® settings were the following: for the pre-phaco, 80 cmH20 of irrigation, 150
      mmHg of vacuum and 25 mL/min of flow aspiration; for sculpt, 80 cmH20 of irrigation, 70% of
      phaco energy and 95% of torsional amplitude, 50 mmHg of vacuum and 25 mL/min of flow
      aspiration; for segment removal: 110 cmH20 of irrigation, 90 of torsional amplitude, 400 mmHg
      of vacuum and 25 mL/min of flow aspiration; for the epinucleus removal: 110 cmH20 of
      irrigation, 230 mmHg of vacuum and 25 mL/min of flow aspiration; for the
      irrigation/aspiration: 65 cmH20 of irrigation, 450 mmHg of vacuum and 25 mL/min of flow
      aspiration; for the visco 65 cmH20 of irrigation, 500 mmHg of vacuum and 30 mL/min of flow
      aspiration. Continous Ozil was used throughout the phacoemulsification. The settings for
      LensX® were the following. For the capsulotomy: diameter 5mm, energy 5 µJ, spot separation 4
      µm, layer separation 3 µm, delta up (lens anterior offset) 300 µm, delta down (lens posterior
      offset) 300 µm. A three-plane incision was used for primary incision at 135 degrees
      (posterior depth 40, 80 and 130%, respectively). Secondary incision was performed at 45
      degrees. For both incisions, energy used was 4 µJ and spot and layer separation was 4 µm. The
      laser pattern for fragmentation was a hybrid combination between chop (two cuts) and
      cylinder.

      Measurements. The surgical and roll-over times for both conventional phacoemulsification and
      FLACS were recorded in a spreadsheet including: start time of patient preparation, start time
      of anesthesia, surgery start time, surgery end time, time needed to transfer the patient to
      resting area, and time of discharge. Specifically, for patients undergoing FLACS, the sum of
      the preparation time and the femtosecond laser time was calculated as well as the time
      between the performance of femtosecond laser procedures and the beginning of
      phacoemulsification surgery, and the time ranging from the moment when the patient entered to
      the femtosecond laser room to the moment where the patient left after the end of the surgery.
      Likewise, the following parameters were calculated in all groups: 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. Likewise, mean phacoemulsification energy used in each procedure
      was also recorded (CDE: cumulative dissipated energy). Finally, 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.

      Statistical analysis. A descriptive analysis of the variables studied including mean,
      standard deviation, maximum and minimum. To analyse the differences between FLACS and MANUAL
      groups in terms of the continuous quantitative variables, the unpaired Student t test was
      applied whenever the normality condition was satisfied (verified with the Shapiro-Wilk test).
      Otherwise, the corresponding non-parametric test was used (Mann-Whitney test). Comparisons of
      categorical variables were performed using the Chi-square test. A homogeneity analysis was
      performed between groups in terms of age and gender to ensure the comparability of groups.
      All these statistical analyses were performed using R software version 3.2.1 (R Foundation
      for Statistical Computing, Vienna, Austria; available at http://www.R-project.org or R
      Development core Team, Vienna, Austria).
    

Intervention name(s): CONVENTIONAL PHACO
Intervention type(s): Procedure
Intervention description(s): Cataract surgery by means of Femtosecond Laser-Assisted Cataract Surgery,
Other intervention name(s): FEMTOSECONDLASER (FLACS)
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)
Primary purpose: Treatment
Keywords: FEMTOSECOND LASER; Femtosecond Laser-Assisted Cataract Surgery; CATARACT SURGERY; phacoemulsification; operation room workflow; public setting