Plasma powered squint surgery with the fugo blade

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Introduction Squint surgery is performed by far fewer surgeons than perform cataract surgery. When fewer profes- sionals and less resources are devoted to a field, advances usually occur at a slower pace. Herein, I describe a technique that has offered considerable improvement in strabismus surgery for me over the past two years. The key to this technique is the appli- cation of a novel technology that has been approved by the US Food and Drug Administration (FDA) for cataract surgery, called the Fugo Blade™ or Plasma Blade™. 1 In use for iridotomies, the Fugo Blade™ was shown to provide bloodless surgery in vascular tissue. Similarly, for vitreoretinal surgery, it has been shown to provide bloodless, resistance free surgery. 2 Resis- tance free, bloodless surgery offers the potential to change the capability of performing strabismus surgery. In other fields, we see that bloodless, resis- tance free incision results in more precise dissection of tissue planes with less trauma to tissue outside of the intended path of incision. 3 Materials and Methods Surgical Equipment. All surgical equipment used in this technique were standard equipment found in most comprehensive texts on the subject, except that the Fugo Blade™/Plasma Blade™ was employed. The lowest Fugo Blade™ power settings (cut power to “low” Daljit Singh, MD, Ravi S. Jit Singh, MD, Harmit Kaur, MD, Kiranjit Singh, MD, Indu Singh, MD, & Ravijit Singh, MD Plasma Powered Squint Surgery with the Fugo Blade The Fugo Blade™/Plasma Blade™ offers important advantages in many types of surgeries, both inside as well as outside of ophthal- mology. As this technology is now mainstream, we evaluated the use of the Fugo Blade™/Plasma Blade™ in strabismus surgery. We demonstrated distinct advantages for using the Fugo Blade™ in squint surgery, which included increased surgeon control and decreased operative time. ABSTRACT Reprints: Daljit Singh, MD, Dr. Daljit Singh Eye Hospital, 1-Radha Soami Road, Amritsar- 143002, India. The authors are from the Dr. Daljit Singh Eye Hospital and Medical Center, Amritsar, India. The authors have stated that they do not have a significant financial interest or other relationship with any product manufacturer or provider of services discussed in this article. ORIGINAL ARTICLE ANN OPHTHALMOL. 2003; 35(1):12–14 12

Transcript of Plasma powered squint surgery with the fugo blade

Page 1: Plasma powered squint surgery with the fugo blade

IntroductionSquint surgery is performed by far fewer surgeonsthan perform cataract surgery. When fewer profes-sionals and less resources are devoted to a field,advances usually occur at a slower pace. Herein, Idescribe a technique that has offered considerableimprovement in strabismus surgery for me over thepast two years. The key to this technique is the appli-cation of a novel technology that has been approvedby the US Food and Drug Administration (FDA) forcataract surgery, called the Fugo Blade™ or PlasmaBlade™.1 In use for iridotomies, the Fugo Blade™ wasshown to provide bloodless surgery in vascular tissue.Similarly, for vitreoretinal surgery, it has been shownto provide bloodless, resistance free surgery.2 Resis-tance free, bloodless surgery offers the potential tochange the capability of performing strabismussurgery. In other fields, we see that bloodless, resis-tance free incision results in more precise dissectionof tissue planes with less trauma to tissue outside ofthe intended path of incision.3

Materials and MethodsSurgical Equipment. All surgical equipment used inthis technique were standard equipment found inmost comprehensive texts on the subject, except thatthe Fugo Blade™/Plasma Blade™ was employed. Thelowest Fugo Blade™ power settings (cut power to “low”

Daljit Singh, MD, Ravi S. Jit Singh, MD, HarmitKaur, MD, Kiranjit Singh, MD, Indu Singh, MD,& Ravijit Singh, MD

Plasma Powered Squint Surgerywith the Fugo Blade

The Fugo Blade™/Plasma Blade™ offers important advantages in

many types of surgeries, both inside as well as outside of ophthal-

mology. As this technology is now mainstream, we evaluated the use

of the Fugo Blade™/Plasma Blade™ in strabismus surgery. We

demonstrated distinct advantages for using the Fugo Blade™ in

squint surgery, which included increased surgeon control and

decreased operative time.

A B S T R A C T

Reprints:Daljit Singh, MD, Dr. Daljit Singh Eye Hospital, 1-Radha Soami Road, Amritsar-143002, India.

The authors are from the Dr. Daljit Singh Eye Hospital and Medical Center, Amritsar,India.

The authors have stated that they do not have a significant financial interest or otherrelationship with any product manufacturer or provider of services discussed in thisarticle.

O R I G I N A L A R T I C L E

ANN OPHTHALMOL. 2003;35(1):12–1412

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and cut intensity to “10”) were used throughout theprocedure. Two different tips were used. One ablationtip of the Fugo Blade™ was 0.75 mm in length and 100microns in thickness. The other was 0.5 mm long and300 micron thick.

Subjects. A total of 30 subjects were studied. Fif-teen patients underwent Fugo Blade™ squint surgery,while an additional 15 patients underwent standardsquint surgery. The selection to either group wasbased on a computerized random selection program.No patients were excluded from the study based onocular pathology or systemic pathology. The patients’ages ranged from 11 months to 8 years of age. Thetype of surgery included in this study was recession—resection of horizontal muscles only. This was chosenin order to facilitate data analysis and interpretation.

Statistical Analysis. Data from each patient wasused to derive two experimental design analysis crite-ria, namely control of surgery and time of surgery.Data for control of surgery was obtained by evaluatingany impediment for the surgeon to proceed withsurgery. For example, need to flush blood from thesurgical field or employ weck cells to remove bloodfrom the surgical field was considered an impediment.Need to cauterize was considered an impediment tothe surgeon. Each incident of surgical impedimentwas recorded for each surgery. Also, the total time ofsurgery based on first conjunctival incision to finalclosure of conjunctiva was recorded for each patient(Figure 1). The two sets of data were evaluated for sta-tistical significance based on a non-parametricapproach employing two unmatched random samples.In both cases, the Wilcoxon Sum of Ranks Test wasemployed. For statistical analysis, the patient data wasnormalized based on the number of muscles operated(Figure 2). For example, if one muscle was operated onthen the number of impediments counted duringsurgery was divided by 1, whereas if two muscles wereoperated on then the number of impediments wasdivided by 2. This was called the “normalized” data.

ResultsThe surgical control based on surgical impediment cri-teria demonstrated a mean 23.6% fewer normalizedsurgical impediments with the Fugo Blade™ groupthan with the standard surgical group. Statisticalanalysis based on Wilcoxon Sum of Ranks Test showeda statistically significant difference between the twogroups with a P < .01. The average surgical time forsquint surgery was 42% less for the Fugo Blade™ groupas compared to the standard group. The average nor-malized surgical time in the standard squint group was12.5 min, whereas the average normalized surgicaltime in the Fugo Blade™ group was 7.3 min. A Wilcox-on Sum of Ranks Test showed a statistically significantdifference between the two groups with a P < .002.

DiscussionTo a large extent, the success of squint surgery isbased on an appropriate surgical plan and surgical

control of the operation. All cases were operated undergeneral anesthesia, thereby the total time of surgerywas quite important. Our objective in this study was toevaluate the potential of the novel Fugo Blade™ tech-nology to improve both the control and time ofsurgery. The Fugo Blade™ is FDA approved forcataract surgery in the US.4 It is a novel technologyand, as such, was designated a unique product codenumber by the FDA. Dr. David Apple of the Moran EyeCenter performed histologic analyses of Fugo Blade™incisions and presented his findings in his KeynoteInnovator’s Lecture at the 2002 American Society ofCataract & Refractive Surgery (ASCRS) meeting. Themethod of creating an incision was well described byDr. I. Howard Fine who stated, “The unit produces amicro-ablation path through the capsule comparableto the effect of a miniature Excimer laser”.5 Also, onincision capability, Dr. F. Hampton Roy stated: “…there was no tactile feedback. In other words, I sawthe tissue being cut but realized that for the first timeI was cutting tissue without any resistance”.6 For thisreason, the surgeon must be very cautious not to allowthe activated Fugo Blade™ incising tip to come in con-

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Fig 1.—Bloodless opening of the conjunctiva with the Fugo Blade™.

Fig 2.—Bloodless ablation path incision of extraocular muscle with the FugoBlade™.

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tact with sclera or cornea since an unwanted ablationtract would be immediately created in these struc-tures. This is an important part of the learning curvefor this exciting new technology. This is also one of thereasons why users of this technology must undergo aninstructional certification course, namely to learnwhat to do as well as what not to do with this device.

The Fugo Blade™ is a lightweight, portable unitthat operates on flashlight size rechargeable batteries,cutting sharper than a diamond blade while providinga total cut time of about one hour duration.7 I believethat the ability to operate on small flashlight sizerechargeable batteries offers maximum safety to mypatients. No electrical shock to the patient is possible.These small batteries transmit a minute amount ofenergy per second to the blunt incising filament.Rather, the system employs a patented tuning systemthat transfers this minute amount of energy into themolecular lattice in the path of incision, thereby caus-es a molecular rearrangement or incision.8 The minuteamount of energy employed results in essentially nocollateral tissue damage to adjacent tissue.9 As thismolecular rearrangement occurs at the ablation tip, itcauses molecular fragments to plug the ends of cutcapillaries, thereby causing a non-cauterizing hemo-stasis.10 This novel hemostasis has been demonstratedin iris, vitreoretinal fronds,11 and ciliary body inci-sions.12 This new form of hemostasis is called “autosta-sis”. Autostasis is an exciting new method ofhemostasis wherein small molecular fragments,which are agitated at the incising tip actually plug theends of capillaries. This precipitates a platelet plugformation. The advantage is that you generate hemo-stasis without burning of the incision walls. The wallsof a scleral incision with the Fugo Blade™ stay white,yet bloodless. Autostasis was presented at the 2002International Society of Refractive Surgery and 2002ASCRS meetings. Furthermore, a mist rises as softtissue is ablated with the Fugo Blade™. This mistsmells like an Excimer laser plume because it pos-sesses vaporized water and small aromatic molecularfragments, as do Excimer laser plumes.13 No nauseat-ing burning smell is emitted because there is notenough energy on the tip to create a diathermy burn.14

These novel advantages allow for the unique surgi-cal capability for the Fugo Blade™. The technologywas chosen as the keynote lecture at the 2001 meetingof the American College of Eye Surgeons as well as theUniversity of Kansas Eyecon 2002 Annual Meeting. Todate, over 500 surgeons have received course certifica-

tion to use this device, thereby the technology hasnow penetrated into a large segment of the oph-thalmic community. The number of studies, as well asthe sites of these studies are rapidly increasing. Forexample, Dr. M. Edward Wilson, Director of Storm EyeInstitute, Charleston, S.C., USA is conducting an in-depth study on the Fugo Blade™. Interested surgeonsmay learn more about this technology by contactingMedisurg Research and Management Corporation inNorristown, PA, USA (Tel: 610-277-3937)15 or going tothe website: www.fugoblade.com. Furthermore, exten-sive human clinicals are now being conducted inmany surgeries in our field as well as outside of oph-thalmology.16

This study confirmed our subjective impression,namely that the Fugo Blade™ provides great advan-tage for squint surgery. This study demonstrates a sta-tistically significant advantage for users of FugoBlade™/Plasma Blade™ for squint surgery by provid-ing dramatic control over this type of surgery as wellas a significant decrease in total time required for thesurgery.

References1. Kellan R, Fugo RJ. Device increases safety, efficiency of cataract

surgery. Ophthalmol Times. 2000;25,22:7–9.2. Singh IR. Managing proliferative vitreo-retinopathy with the

Fugo blade—A case report. Tropical Ophthalmol. 2001;1,3:24–5.3. Kronemyer B. Fugo blade uses low-level energy to create anterior

capsulotomy. Ocular Surg News. 2000;18,21:45–6.4. Hoffman RS. New Dimensions in Cataract Surgery. Ophthalmolo-

gy Management. 2003; Buyer’s Guide:45–8.5. Fine IH, Hoffman RS, Packer M. Highlights of the 2002 ASCRS

symposium, Part I. Eyeworld. 2002;7.7:38.6. Roy FH. Course for Fugo blade is enlightening, surgeon says. Ocu-

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Refract Surg. 2002; 28,4:573–4.10. Kent C. Transciliary filtration—Without bleeding. Ophthalmol

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reoretinal surgery with plasma knife may be a new frontier. Ocu-lar Surg News. 2001;19,19:80–3.

12. Singh D, Singh K. Tranciliary filtration using the Fugo blade. AnnOphthalmol. 2002;34,3;183–87.

13. Hidalgo-Simon A. Plasma knife provides clean and accurate cutfor capsulorhexis. Eurotimes. 2002;7,11;27.

14. Fugo RJ, Singh D, Fine IH. Automated Fugo blade capsulotomy: Anew technique and a new instrument. Eyeworld. 2002;7,9;49–54.

15. Website address: www.fugoblade.com.16. Winn MC. Broad applications seen for plasma blade. Ocular Surg

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