Foreword

Today in vitreoretinal surgery, things are coming together — literally. We have seen some very significant advances make their way into our ORs in a relatively short period of time. After a somewhat slow start, microincisional vitrectomy surgery (MIVS) is becoming the preferred approach for a growing number of surgeons. MIVS, with its newly designed cannulated trocars and small-gauge instruments, now allows truly robust removal of core vitreous and outstanding control of the surgical field on par with its 20-gauge predecessor.

The performance of small-gauge instrumentation has been driven forward further by its marriage with the latest surgical platforms, which integrate multiple devices into single systems and feature advanced fluidics, vitreous cutting technology and IOP control. Notably, our newest posterior segment platforms incorporate state-of-the-art anterior segment capabilities. In the case of the CONSTELLATION® Vision System (Alcon), a 532-nm laser is integrated as well.

Together, these types of advances enable more efficient surgery, and more efficiency means enhanced safety. Today's technologies benefit surgeons and their practices and, most importantly, patients. In this supplement to Retinal Physician, surgeons describe what they consider to be the benefits of the CONSTELLATION® Vision System, in particular when performing challenging complex procedures.

Dr. Maria Berrocal explains how small-gauge instruments improve her ability to approach complex retinal detachments. The retina is stabilized by advanced fluidics, and aggressive membrane dissection can be accomplished with the small-gauge cutters, greatly reducing the need for forceps and scissors. Enhanced intraoperative IOP control reduces bleeding during treatment of diabetic traction and rhegmatogenous retinal detachments. The integration of laser technology, wide-field viewing and small-gauge illumination probes allows extensive anterior laser therapies that were difficult to perform in the past. Dr. Carl Regillo outlines the steps surgeons are taking in order to improve outcomes in surgery for retained lens material. He points out how current fluidics and high-speed vitrectomy probes sometimes allow management of these cases without the need for primary pars plana lensectomy.

Dr. Wayne Solley reports on his new technique for removing an IOL that has dislocated into the vitreous. Taking advantage of the efficient core vitrectomy, well-controlled surgical field and bright chandelier lighting provided by the CONSTELLATION® System, he cuts the IOL into several pieces and removes them through the pars plana, eliminating the need for an additional anterior segment incision.

Finally, I describe how current thinking about the approach to management of co-existing retinal pathology and cataract has been evolving. The CONSTELLATION® System, now equipped with OZil® torsional phaco technology, is a major factor in making one trip to the OR for these patients instead of two a viable option. We are finding that combined surgery results in less related morbidity for patients as well as faster healing and recovery of visual acuity.

— Timothy G. Murray, MD, MBA, FACS

Closing

CONSTELLATION^® Vision System Indications for Use With Laser

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.
The PUREPOINT^® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
• Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms.
• Iridotomy/Iridectomy for treatment of chronic/primary open angle glaucoma, acute angle closure glaucoma and refractory glaucoma.
• Trabeculoplasty for treatment of chronic/primary open angle glaucoma and refractory glaucoma.
• And other laser treatments including: internal sclerostomy; lattice degeneration; central and branch retinal vein occlusion; suturelysis; vascular and pigment skin lesions.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Contraindications: Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber of vitreous humor) are poor candidates for LIO delivered laser treatments.
Complications: Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used.

Warnings and Precautions:

• The disposables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
• Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
• Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
• Vitreous traction has been known to create retinal tears and retinal detachments.
• The closed loop system of the CONSTELLATION^® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
• Leaking sclerotomy may lead to post operative hypotony.
• Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at 532nm.
• Important Safety Information: Warnings and Cautions: A complete listing is available in the CONSTELLATION^® Vision System Operators Manual. To obtain a copy, please contact Alcon Customer Service.

INFINITI^® System Indications for Use

Indication: The INFINITI^® Vision System with OZil^® IP is indicated for emulsification and removal of cataracts, vitreous aspiration and cutting associated with anterior vitrectomy, and bipolar coagulation.
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Warnings: Appropriate use of INFINITI^® Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottle heights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significant temperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.
Adjusting aspiration rates or vacuum limits above the preset values, or lowering the IV pole below the preset values, may cause chamber shallowing or collapse which may result in patient injury.
When filling handpiece test chamber, if stream of fluid is weak or absent, good fluidics response will be jeopardized. Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye.
Ensure that tubings are not occluded or pinched during any phase of operation.
The consumables used in conjunction with Alcon instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
AEs/Complications: Use of the NeoSoniX^®, OZil^® torsional, U/S, or AquaLase^® handpieces in the absence of irrigation flow and/or in the presence of reduced or lost aspiration flow can cause excessive heating and potential thermal injury to adjacent eye tissues.
ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

Disclosures

Maria H. Berrocal, MD, has consulted for Alcon and Alimera.

Timothy G. Murray, MD, is a consultant for Alcon and ThromboGenics, Inc.

Carl D. Regillo, MD, has received research support from, and provided consulting for, Alcon and Bausch + Lomb. He has consulted for Abbott Medical Optics (AMO).

Wayne A. Solley, MD, has received honoraria and educational grants from Alcon.