Integrating the LenSx Laser Laser into your Clinic: Our advice for those considering it (DAY) Facilitator: (Name)
LenSx Laser Important Safety Information Caution United States Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Indication The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Restrictions Patients must be able to lie flat and motionless in a supine position. Patient must be able to understand and give an informed consent. Patients must be able to tolerate local or topical anesthesia. Patients with elevated IOP should use topical steroids only under close medical supervision. Contraindications Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength Descemetocele with impending corneal rupture Presence of blood or other material in the anterior chamber Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only) Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape Corneal thickness requirements that are beyond the range of the system Corneal opacity that would interfere with the laser beam Hypotony or the presence of a corneal implant Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) History of lens or zonular instability Any contraindication to cataract or keratoplasty This device is not intended for use in pediatric surgery. Warnings The LenSx Laser System should only be operated by a physician trained in its use. The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create potential hazards. The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction. Precautions Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. Discard used Patient Interfaces as medical waste. AEs/Complications Capsulotomy, phacofragmentation, or cut or incision decentration Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure Capsular tear Corneal abrasion or defect Pain Infection Bleeding Damage to intraocular structures Anterior chamber fluid leakage, anterior chamber collapse Elevated pressure to the eye Attention Refer to the LenSx Laser Operator s Manual for a complete listing of indications, warnings and precautions.
What is it?. What is it NOT?! Laser Application to Cataract Surgery technique Provides Precision in technique = Outcomes 3 Applications in the Cataract procedure -Capsulotomy -Nucleus Fragmentation -Corneal Incisions Not a replacement for the Phaco System
Patient Flow Typical Patient Flow LSX13076SK
New Terms: Common to LenSx Laser Applanation: Centration and contact on cornea Gamma: Used to illuminate dark eyes Gui: Graphic User Interface (ie. screen) Live OCT: Anatomical live scan Meniscus: Contact interface Objective: Docking head PI: Patient Interface (tubing always temporal) RFID reader: Coded PI Sealed Beam Pathway: Sealed laser path LSX13076SK
Nursing Staff Considerations: Pre-Op Dilate and start IV (if IV used), (No IV meds) Sedation 30 min Prior (as per MD) Patient positioned in appropriate gurney/chair Ensure eye is well dilated (6mm) Remind patient: They will be awake / involved Remind patient: suction achieved, no move or talk If suction broken, procedure completed manually Coach patient: Presence of Red Ring post op Red Ring hematoma present approx. 3-10 days LSX13076SK
Considerations and Contraindications Listed Contraindications: See LenSx Laser Operator s Manual and the Brief Statement provided at the beginning of this presentation Consider prior corneal surgery & result Patient situations that may affect access, success - Cognitive status, ability to cooperate, assist - Physical anatomy such as small eye, heavy brow, nose
Patient Considerations Anatomy, Small Eye, Dock may not be possible - If not, case proceeds as normal cataract case - Tight orbit, Speculum access too tight for PI - Protruding nose/brow, Tilt head (re-position) - Patient must lay still, verbally coach, interact
Sealed Beam Laser- Warning Sign
LenSx Laser: Patient Alignment & Identification
Patient View as Objective is Aligned
LenSx Laser The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Indications for Use
The OR Suite or Surg / Ref Suite LenSx Laser: Not designed to be moved once in Suite Patient and staff access should allow freedom of movement around laser, no crowding Suite temperature and humidity critical: 18-24º C (65-75º F), 30-40% Humidity If in OR near Phaco, LenSx Laser = still a clean procedure
Nursing Staff Considerations: In Room Medications: Pre-procedure: Per MD request, Follow protocol Note: MD recommendations through LenSx Laser user discussion not Alcon position or recommendation No topically applied medicine regimen can be in any form of gel or viscous suspension (Per LenSx Laser), as this may impact the docking procedure and/or the applied treatment Instruments: Mayo Stand, Lasik Speculum, Femto-Spatula, Alcohol wipes, Weck Cells, 15ml BSS, Sterile 4x4s, unique cataract instruments (ie. Nucleus splitter, Curettes) *Trademarks are property of their respective owners
Nursing Staff Considerations: In Room Verbal: Remind, first portion of case, Reinforce cooperation, call time remaining in Treatment, Verbal anesthesia. Explain Red Fixation light Gurney alignment, must be straight / axis with LenSx Laser
Nursing Staff: Transfer to OR Suite Once LenSx Laser portion complete, notify patient next portion may follow shortly or with minimal delay* *(depending on location and install, LenSx Laser may be in OR suite vs Laser Suite) Remind patient, laser portion complete cataract is prepared for removal. Next step is to remove and place new lens. Remind patient, vision may be blurry, not to sit up as the room is prepared for next phase of their procedure. Anesthesia may be / usually administered during this time. Patient told next step they will not be as involved, more sedate
Nursing Considerations: Post Op Recovery: Same as for standard cataract case Remind patient of Hematoma Red Ring this is Normal and patient dependent Tylenol* for any discomfort (per MD) *Trademarks are property of their respective owners
Brief Review and Questions How is LenSx Laser different from cataract procedure Which patients are candidates for LenSx Laser Identify the patient accordingly for surgical team/staff Inform MD about status of pupil size and pt affect Note patients anatomy, small stature, small eye, etc Not all patients may be successfully docked
Brief Review and Questions Patient will be awake and participatory in LenSx Laser portion LenSx Laser is making incisions and fragmenting the cataract for removal Cataract procedure proceeds as standard Remind patient there may be some redness
2014 Novartis 7/14 Questions