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Трейдомед инвест / Страничка клинициста / Posterior Pole Applications of Transpupillary Thermotherapy Augmented with Indocyanine Green

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2017-06-30 22:59:35

В рамках World Glaucoma Congress в Хельсинки 30 июня 2017 г. компания "Optovue" 

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"Changing the Glaucoma Paradigm: Detection and Management with OCT & OCTA" 

Posterior Pole Applications of Transpupillary Thermotherapy Augmented with Indocyanine Green

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INDOCYANINE GREEN-ENHANCED TRANSPUPILLARY THERMOTHERAPY OF CHOROIDAL MELANOMA

Choroidal melanoma is the most common intraocular malignant tumor of the eye in the adult population. Transpupillary thermotherapy (TTT) has been used successfully in the treatment of choroidal melanomas.1-5 During TTT, near-infrared radiation energy (810 nm) from a diode laser is delivered to the tumor through a dilated pupil. Experimental models show that the temperature of the tumor increases to 45 - 60°C (intermediate-level hyperthermia) with an exposure of 1 minute or more.6 These levels of hyperthermia produce a direct cytotoxic effect (tumoricidal phenomena) on tumor cells.

Indocyanine green (ICG) is a water-soluble anionic dye approved by the U.S. Food and Drug Administration for indocyanine angiography in ophthalmology decades ago.7 ICG is safe, inexpensive, and associated with only isolated case reports of adverse reactions.8 ICG exhibits an absorption spectrum in the infrared band. In experimental models9-11 and clinical studies of choroidal melanoma, this molecule in combination with an infrared diode laser used in a thermal mode acts synergistically to almost double the tissue destruction effect from TTT when used alone.12 ICG, when injected prior to a TTT treatment, acts as a chromophore enhancing the photothermal effect and as a fluorophor producing photochemical effects resulting in a photodynamic therapy reaction (i-TTT).

Fig 1c. Red free fundus


Fig 1d. Middle FA frame 3 months after the second session disclosed residual tissue without evidence of activity. BCVA: 20/60.

We evaluated 25 eyes of 25 patients with small and mediumsize choroidal melanoma treated with i-TTT in a retrospective noncomparative interventional study. Fifteen ml of an aqueous solution containing 75 mg of ICG was administered as a single IV bolus into a cubital vein, followed by injection of a 10 ml saline flush, 10 minutes before beginning the treatment with the 810 nm IRIS Medical OcuLight® SLx laser. The laser application was initiated using 60-second exposure duration and 550 mW power over a 3-mm diameter spot. The power was raised step-wise by 50 to 100 mW steps until the surface of the tumor developed a grayish color toward the end of the exposure time. The entire surface of the tumor was treated with confluent 3-mm diameter sequential applications. A smaller beam diameter was sometimes used when treating near the macula or the optic disc. Table 1 compares the tumoral volume before and after the treatment.

Considering the small and medium-size tumors in different analyses, both groups showed a statistically significant (p <0.05) reduction in tumor height and volume during the 3 and 6 month follow-up and at the final visit (length of time, or a range of time). After a mean of 2.4 sessions of i-TTT (range: 1 to 5) all of the cases, but one, reached the aim of the therapy, which was to obtain a volume reduction with shrinkage of the tumoral tissue without clinical evidence of growth during the follow-up. Fifteen (88%; 15/17) of the small, and four (50%; 4/8) of the medium-size lesions showed a complete volume involution after treatment and manifested clinically as flat scar tissue (Figure 1).
Table 1. Results of TTT enhanced with ICG (i-TTT) in choroidal melanomas.


In the rest of the cases, some grade of residual and inactive tumoral tissue was observed at the final visit. Our experience leads us to believe that i-TTT may synergistically increase tissue absorption of 810 nm infrared laser energy and enhance tissue destruction by combined photothermal and photochemical effects in small and medium-size melanomas as indicated in experimental and clinical studies. We further believe that i-TTT may expand the indications for TTT in the treatment of intraocular tumors.

I-TTT IN CHOROIDAL NEOVASCULAR MEMBRANE SECONDARY TO AGE-RELATED MACULAR DEGENERATION

The additive effect of TTT and ICG could be used with benefit in the management of choroidal neovascularization (CNV). We herein provide a preliminary report of our experience in 15 patients with occult CNV using i-TTT as a reasonable alternative in cases of CNV due to age-related macular degeneration (AMD) in patients who are not candidates for conventional focal laser photocoagulation13 or photodynamic therapy (PDT) using Visudyne.14

All the treatments were performed with the IRIS Medical OcuLight SLx laser delivered to the subretinal neovascular area through the Ocular Mainster Wide Field contact lens (0.68x image magnification, 1.5x laser beam magnification). Fifteen ml
of an aqueous solution containing 75 mg of ICG was administered as a single IV bolus into a cubital vein, followed by injection of a 10 ml saline flush five minutes before beginning the treatment with the laser. The laser treatment was performed with a beam diameter of 1.2, 2.0 or 3.0 mm (depending on the diameter of the CNV) for 60 seconds duration at a power setting ranging from .36 to 1 W (Table 2).

Table 2. Laser treatment parameters for i-TTT in CNV secondary to AMD.

The endpoint was an area of no visible color change to a lightgray appearance. Care was taken to ensure that the entire lesion border was covered with the treatment beam. A security area of 500 - 1000 µm from the border of the lesion was desirable. Immediately after the diode laser application, ICG angiography was conducted without further ICG administration, and the sub-visible laser application was confirmed when hypo-fluorescence of the treated area was observed.

Ten eyes received treatment once and five two times. Occlusion of CNV and resolution of the exudation were confirmed in 13 of 15 eyes (86.6%) by the fluorescein angiography (FA) at the final of the follow-up visits (Figure 2).

In two cases, the CNV occlusion was not completely achieved: The former remained stable despite that the FA showed a mild escape of dye in late frames; the latter continued growing after treatment resulting in disciform scar formation. Because of the presence of scar tissue beneath the fovea, no additional treatment was recommended. Preoperative visual acuity (VA) ranged from 6/200 to 20/50 (mean: 20/310). Postoperative VA at the final follow-up examination ranged from hand motion to 20/30 (mean: 20/336). VA improved in 4 eyes (26.6%) by more than two lines in the Snellen chart classification, remained the same in 7 (46.6%), and deteriorated by more than two lines in 4 (26.6%).

No severe complication occurred during or after the treatment. Nevertheless, two patients developed a post-treatment choroidal atrophy. Five eyes (33.3%) required re-treatment for the management of both recurrence (three cases) and persistence of the CNV (two cases). All the recurrence occurred in relationship to the border of the membrane. This single-center, retrospective pilot study examining the use of ICG-enhanced TTT (i-TTT) found potential short-term VA stabilization in patients with the occult subtype of CNV in AMD.

Fig 2a. Pre-treatment. Early FA shows occult, kidney-shaped CNV with exudative manifestations. VA: 20/50
Fig 2b. Pre-treatment. Late FA.









Fig 2c. 3 Months post-treatment. After one session of i-TTT, early FA shows complete resolution of the exudation. VA: 20/30.
Fig 2d. 3 Months post-treatment. Late FA.








REFERENCES


1. Oosterhuris JA, Journee-de Korver HG, Makebeeke-Kemme HM, Bleeker J. Transpupillary thermotherapy in choroidal melanomas. Arch Ophthalmol 1995;113:315-321.
2. Godfrey DG, Waldron RG, COMT, Capone Jr A. Tranpupillary thermotherapy for small choroidal melanoma. Am J Ophthalmol 1999;128:88-93.
3. Robertson DM, Buetter H, Bennett SR. Tranpupillary thermotherapy as primary treatment for small choroidal melanomas. Arch Ophthalmol 1999;117:1512-1519.
4. Shields CL, Shields JA, Perez N, Singh AD, Cater J. Primary transpupillary thermotherapy for small choroidal melanoma in 256 consecutive cases. Outcomes and limitations. Ophthalmology 2002;109:225-234.
5. Stoffelns BM. Primary transpupillary thermotherapy (TTT) for malignant choroidal melanoma. Acta Ophthalmol Scand 2002;80:25-31.
6. Journee-de Korver JG, Verburg-van der Marel EH, Oosterhuris JA, van Best JA, de Wolff-Rouendaal D. Tumoricidal effect of hyperthermia by near infrared irradiation on pigmented hamster melanoma. Lasers Light Ophthalmol 1992;4:175-180.
7. Flower RW, Hochheimer BF. Clinical infrared absorption angiography of the choroid. Am J Ophthalmol 1972;73:458-459.
8. Hope-Ross M, Yannuzzi LA, Gragoudas ES, et al. Adverse reactions due to indocyanine green. Ophthalmology 1994;101:529-533.
9. Greenwell TJ, Wyman A, Rogers K. Choromophore-enhanced 805 nm laser therapy for gastrointestinal neoplasia. Eur J Surg Oncol 2001;27: 368-372.
10. Chen WR, Adams RL, Bartels KE, Norquist RE. Chromophore-enhanced in vivo tumor cell destruction using an 808-nm diode laser. Cancer Lett 1995;94:125-131.
11. Chen WR, Adams RL, Higgins AK, Bartels KE, Norquist RE. Photothermal effects on murine mammary tumors using indocyanine green and an 808-nm diode laser: An in vivo efficacy study. Cancer Lett 1996;98: 169-173.
12. Chong LP, Ozler SA, de Queiroz JM Jr, Liggett PE. Indocyanine greenenhanced diode laser treatment of melanoma in a rabbit model. Retina 1993;13:251-259.
13. Macular Photocoagulation Study Group. Subfoveal neovascular lesions in age-related macular degeneration. Guidelines for evaluation and treatment in the macular photocoagulation study. Arch Ophthalmol 1991;109:1242- 1257.
14. Photodynamic therapy of subfoveal choroidal neovascularization in agerelated macular degeneration with verteporfin: One-year results of 2 randomized clinical trials—TAP report. Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group. Arch Ophthalmol 1999;117:1329-1345.

La Morita Mission: Eyecare for Those in Need (Robert N. Johnson, M.D. West Coast Retina, San Francsico, CA)

Just across the California border in the shadow of San Diego lies Tijuana. Most people know Tijuana as a kind of cheesy border tourist town. Few venture to the eastern portions where substantial poverty grows in what is the fastest growing area of Mexico. Driven by hope of a job, or possibly crossing the border, Mexicans are migrating to this area in greater numbers. Approximately 200,000 people live in this region of small towns, or ‘colonias’. Jobs in local factories pay poorly, and medical care is lacking, or unaffordable. Houses have dirt floors, no running water, and the roads are unpaved. These people need help.

In 1997, the La Morita Mission was founded by Fr. Roberto Callahan. Friends Helping Friends International based in Chula Vista, California, was subsequently formed to provide assistance in this endeavor. Through dedication, hard work, and countless hours of volunteer efforts, the San Eugenio Community Clinic became a reality on August 30, 2003. The Rotary Club in San Diego has provided a generous grant to equip this medical facility, including an eye examination room.

My involvement with this clinic has come about through my church’s youth group. For the last 3 summers, my oldest son has worked at La Morita, including helping with the construction of the clinic. For me, it has been particularly rewarding to help with first efforts organizing an eye care program. The clinic has excellent, but basic equipment. In order to treat various retinal disorders, access to a laser was essential. I have used IRIDEX’ IRIS Medical OcuLight GL (532 nm) in the clinic for a number of years and have experienced its consistent reliability and ease of use.

The ability to transport this compact laser made it ideal for my work at La Morita. Air travel with this laser has been quite simple. I have utilized a small hard-sided photography equipment case made by Pelican. Using high density foam to cushion the sides, I can transport the laser, and foot pedal in this smaller case that easily fits in the overhead compartments on airlines. I have been relieved that carrying this through airport security has not been a problem, either. I carry the indirect ophthalmoscope attachment in a separate carry-on with other supplies. I have also utilized on one of my trips, the OcuLight SL/SLx infrared (810 nm) laser for treatment of neovascular glaucoma. These seemingly indestructible lasers have been completely reliable.

My efforts in La Morita are a developing endeavor, but my 5 trips have affirmed the substantial need. As the prevalence of diabetes is very high, screening diabetics and treating retinopathy is most common. However, the pathology is varied, and seeing more advanced disease, such as cases of vitreous hemorrhage and retinal detachment due to X-linked retinoschisis, only underscores the need to expand this program further. Currently, I am unable to perform vitreoretinal surgery, but hope to be able to develop this aspect of care as well.

Dr. Johnson at the La Morita Mission, putting the OcuLight GL laser to use.

The personal satisfaction from these efforts has been immense. The dedication of the sisters and volunteers in the clinic is truly humbling. The patients are a pleasure to work with and extraordinarily grateful. Although I return home from these trips tired, I feel that I am the one who has benefitted from the experience and I look forward to my next trip. Finally, I am very grateful for the substantial assistance that Eduardo Arias and IRIDEX has provided to me. The availability of the staff, and assistance with equipment and advice is truly unique in the industry.

For more information on Friends Helping Friends International, go to www.fhfinternational.org.

Point-Counterpoint IV: Surgical Management After Tube-Shunt Failure:
What’s the Next Step? Cyclophotocoagulation is an Alternative
(Douglas E. Gaasterland, M.D. University Ophthalmic Consultants of Washington Chevy Chase, MD)

INTRODUCTION

We treat the intraocular pressure (IOP) in glaucoma with medical and surgical interventions, with the goal to achieve sufficient reduction in the steady-state IOP level to inhibit further vision loss.1,2 The IOP reflects the balance of steadystate aqueous humor inflow and outflow. Steady-state inflow is relatively IOP independent, equal in most species to about 1% of anterior chamber volume per minute, in the absence of medications or ciliary surgery. When relatively high resistance to outflow develops, as in the primary and secondary open- and closed-angle types of glaucoma, the IOP rises passively to provide sufficient driving force for outflow, through the conventional and uveoscleral pathways, to be equal to inflow. Our interventions for glaucoma enhance outflow (miotics, prostaglandin analogues, various filtering procedures), reduce inflow (beta blockers, alpha antagonists, carbonic anhydrase inhibitors, ciliary destructive procedures), or both. Interventions fail when outflow resistance is so high that IOP rises to a level threatening the optic nerve and retinal ganglion cells.

Tube-shunt procedures lower IOP by providing an alternative outflow pathway, reducing outflow resistance. They fail when the resistance remains too high despite the alternative pathway being present, though there usually is some outflow. In such a situation, the ophthalmic surgeon has several options: 1) revise the existing tube-shunt, 2) place another tube-shunt in a new location, 3) do a standard filtering surgery with adjunctive antifibrotic in a new location, 4) do a cyclophotocoagulation [or other procedure to reduce ciliary function], or 5) observe without additional intervention.

CYCLOPHOTOCOAGULATION—BRIEF HISTORY

There is a nearly 145-year history in ophthalmology of ciliary body surgery to reduce aqueous inflow (see Bietti3). In 1937, Vogt was first to report successful penetrating diathermy, a procedure that became widely used for ciliary ablation.4 This was superseded by cyclocryotherapy in the 1960’s, with the associated success and problems this procedure induces,5 and that was superseded by cyclophotocoagulation for ciliary ablation after laser-based ophthalmic systems became available in the late 1970’s. Beckman and co-workers introduced transscleral treatment with continuous-wave ruby laser in 1972 and with neodymium laser in 1973.6,7 There followed about 15 years of development of laser systems and procedures for this purpose with introduction of non-contact and then contact Nd:YAG systems, and later, smaller, less expensive, portable diode laser-based systems. With wider availability of diode laser systems, transscleral cyclophotocoagulation (TSCPC) has become an outpatient, office-based procedure.

CYCLOPHOTOCOAGULATION—DIODE LASER TRANSSCLERAL METHOD


A surgical level of peribulbar, and often retrobulbar, local anesthesia is required.

Laser energy is delivered from the source by a fiberoptic, preferably with a spherical tip. The fiber is oriented either perpendicular to the scleral surface or parallel to the visual axis so that the line of travel of the light will encounter the ciliary processes inside the eye. These processes are near the limbus. The spherical tip, which must be optically clean, indents surface tissues, clearing blood from superficial vessels in the treatment pathway.

The extent of treatment varies, usually being 3 or 4 quadrants, with about 7 applications per quadrant. Each application is about 4 to 6 J, accomplished with proper duration of power at 1.25 to 2.5 W. I favor lower power and longer duration to achieve 5 to 6 J per application. This reduces the occurrence of audible “pops” during treatment, which are the result of boiling of water in the target tissue.

INDICATIONS AND RESULTS

There are more than 100 papers in the literature dealing with short to intermediate-term outcomes after TSCPC for a variety of challenging glaucoma conditions. The conditions include neovascular glaucoma, recalcitrant chronic open-angle glaucoma after previous surgery, aphakic glaucoma, pseudophakic glaucoma, chronic partial or total angle-closure glaucoma, aniridia, iridocorneal endothelial syndrome, and other lessfrequent problems. Most of the reports are of case series with a variety of diagnoses, and some present observations of interesting individual cases. None report prospective, random assignment comparisons with other methods of management. In most of these reports, the 1 to 2 year outcome in the series is “successful control of IOP” in about two-thirds of treated eyes, some of which required more than one step of ciliary treatment. In the various series of these eyes with severely threatening glaucoma, there appears to be a 12 - 25% occurrence of falloff of visual acuity (VA) by two lines or more on the Snellen chart, with the remainder having VA either unchanged or slightly improved.

An Illustrative Case - Before: 4 meds, IOP 45. TSCPC performed. This is 7 months later: 4 meds, IOP 18.

In reviewing many of these papers I found only one study of outcomes of cyclophotocoagulation after failure of a tube-shunt filtering procedure. Thus, this article is not aided or hampered by much systematic data. The one study is by Semchyn, et al., of 21 eyes of 21 patients receiving supplemental TSCPC after failure of a previous tube-shunt procedure; there was an initial mean IOP of 35 mm Hg.8 Laser treatment was followed by 7 to 58 months of follow-up. During this time, 7 eyes needed a second step of laser treatment. At the end of follow-up, 15 eyes were considered a success, having an IOP of 21 mm Hg or less, with continued medical treatment. Ten of the 21 eyes had unchanged or improved VA, while the remaining eyes had a falloff of vision of one or more lines on the Snellen chart.

AN ILLUSTRATIVE CASE

In the past two years of 30 procedures in my office, most for neovascular glaucoma, I have done only one diode TSCPC treatment for a failed tube shunt, in a complex situation.

Mr. K was 79 years old when referred for expedited evaluation of an uncomfortable right eye with IOP in the mid-40’s despite 4 medications. History: Primary open-angle glaucoma and type II diabetes mellittus x 30 years. Status post panretinal photocoagulation and scatter photocoagulation for proliferative diabetic retinopathy and diabetic macular edema. Phacoemulsification with anterior chamber (AC) intraocular lens (IOL) 4 years ago. Uveitis glaucoma hyphema (UGH) syndrome. Diode TSCPC. Recurrent UGH. Remove AC IOL. Recurrent glaucoma. Upper temporal (UT) Ahmed tube-shunt 2 years ago. On exam: VA count fingers (CF) 1 ft. UT tube. IOP 45. Peripheral anterior synechia 3 quadrants. Foveal scar. I did a repeat diode TSCPC of 25 applications at 1.25 W and 4.5 seconds to 3 ? quadrants. Mild post-treatment hyphema. IOP slowly fell to the high teens on 4 medications at 5 months. VA CF 3 ft. Comfortable. At 9 months, IOP was 9 mm Hg and vision unchanged.

CONCLUSION

TSCPC, especially with diode laser systems, due to their more gentle effects on eye tissue, can reduce inflow sufficiently and effectively, when combined with continued medical treatment, to bring the aqueous circulation into balance.

Results from a small number of cases indicate laser TSCPC is an effective intervention when a tube-shunt procedure fails. For TSCPC to be effective there is a need for the eye to have some outflow.9 Despite too high an IOP, eyes with tube-shunt failure probably have some outflow, though insufficient to balance aqueous humor inflow at a tolerable IOP. TSCPC, especially with diode laser systems, due to their more gentle effects on eye tissue, can reduce inflow sufficiently and effectively, when combined with continued medical treatment, to bring the aqueous circulation into balance.

The American Academy of Ophthalmology panel that reviewed cyclophotocoagulation in 2001 concluded that the procedure “... is indicated for patients with refractory glaucoma who have failed trabeculectomy or tube shunt procedures.”10 Data to substantiate the latter are meager.

There is an opportunity and need for a prospective, random assignment study of management when tube-shunt procedures fail. In at least some cases, cyclophotocoagulation is helpful. Unfortunately, the magnitude and duration of improvement and the survival of treated eyes before failure of cyclophotocoagulation is not yet clear. Thus, there is a paucity of pilot data to allow formulation of a null hypothesis and calculation of a sample size for the clinical study.

REFERENCES

1. The AGIS Investigators. The Advanced Glaucoma Intervention Study. 7. The relationship between control of intraocular pressure and visual field deterioration. Am J Ophthalmol 2000;130:429-40.
2. Heijl A, Leske MC, Bengtsson B, et al. Reduction of intraocular pressure and glaucoma progression. Results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002;120:1268-79.
3. Bietti G. Surgical interventions on the ciliary body. New trends for the relief of glaucoma. JAMA 1950;142:889-96.
4. Vogt A. Versuche zur intraokularen Druckherabsetzung mittelst Diathermieschadigung des Corpus cilare (Zyklodiathermiestichelung). Klin Monatsbl Augenheilkd 1936;97:672-7.
5. Caprioli J, Strang SL, Spaeth GL, Poryzees EH. Cyclocryotherapy in the treatment of advanced glaucoma. Ophthalmology 1985;92:947-54; with Discussion by Bellows AR.
6. Beckman H, Kinoshita A, Rota AN, et al. Transscleral ruby laser irradiation of the ciliary body in the treatment of intractable glaucoma.Trans Am Acad Ophthalmol Otolaryngol 1972;76:423-35.
7. Beckman H, Sugar HS. Neodymium laser cyclocoagulation. Arch Ophthalmol 1973;90:27-8.
8. Semchyshyn TM, Tsai JC, Joos KM. Supplemental transscleral diode laser cyclophotocoagulation after aqueous shunt placement in refractory glaucoma. Ophthalmology 2002;109:1078-1084.
9. Spaeth GA. Discussion of Gaasterland DE and Pollack IP. Initial experience with a new method of laser transscleral cyclophotocoagulation in severe glaucoma. Trans Am Ophthalmol Soc 1992;90:225-46.
10. Pastor SA, Singh K, Lee DA, et al. Cyclophotocoagulation. A report by the American Academy of Ophthalmology. Ophthalmology 2001;108:2130-8.

IRIS Medical EndoProbe Handpieces

IRIDEX added four new products to its family of disposable endophotocoagulation probes: the Endo Ocular Adjustable and Intuitive probe, the Endo Ocular Illuminating probe, the Stepped EndoProbe handpieces, and the 23 Gauge Straight EndoProbe handpiece. All probes are compatible with IRIS Medical green (532 nm) and infrared (810 nm) photocoagulators, and competitive laser systems that accept a universal SMA connector.

IRIS Medical Endo Ocular Probes
Adjustable and Intuitive


The fiber optic of the Adjustable and Intuitive probe, can be continuously adjusted over a wide range of angles (0-90°) for full coverage of the peripheral retina without removing the probe from the eye. The fiber optic extends in a logical motion and bends more sharply as the slider is pushed forward, and offers consistent mode quality and spot size across all angles.















Illuminating

The new Endo Ocular Illuminating probes combine white light illumination with laser delivery in one convenient handpiece. Its true 20-gauge needle and bayonet style tip design permits simultaneous wide-field illumination and precise laser spots. It is compatible with illumination sources from Alcon, Bausch & Lomb and Synergetics (adapter required).


IRIS Medical Stepped EndoProbe Handpieces

Stepped EndoProbe handpieces offer a smooth, gently tapered needle which permits the angled 45° tip to be inserted through either standard 20 or 25 gauge cannulas for full coverage of the peripheral retina. These EndoProbes offer a rigid, fixed angle alternative to flexible tip directional probes and increase endophotocoagulation options available to vitreoretinal surgeons.

The 20-24 gauge, 45° angle Stepped EndoProbe permits insertion through a straight cannula. This offers an alternative to the standard angled probe for surgeons who prefer to work through a cannula or who don’t use a cannula but prefer a smaller diameter tip.

The 25-30 gauge 45° angle Stepped EndoProbe is a smooth, gradually tapered needle that permits the angled tip to be inserted through a standard 25 gauge cannula. Its rigid, fixed angle provides a sturdy alternative to flexible tip directional probes. It is the only fixed angle probe available for 25 gauge surgery.

IRIS Medical 23 Gauge Straight EndoProbe Handpiece


This EndoProbe offers similar rigidity to 20 gauge instrumentation while providing the benefits of “sutureless” 25 gauge instruments, and is compatible with 23 gauge vitrectomy instrumentation.

Existing IRIS Medical EndoProbe Handpieces

The existing family of IRIS Medical probes includes 20 gauge: straight, passive aspirating, active aspirating, angled, and illuminating models; and 25 gauge straight.

Furthermore, the DioPexyTM Probe and G-Probe® offer transscleral treatment of retinal and glaucoma pathologies, respectively. Existing IRIS Medical EndoProbe Handpieces

IRIS Medical Training

TRAINING AVAILABLE ON IRIS MEDICAL PRODUCTS IRIDEX will provide two types of training seminars on its IRIS Medical products at the IRIDEX facility in Mountain View, CA.

BASIC IN-SERVICE/TRAINING (1 DAY SEMINAR) This seminar will provide useful knowledge on the proper use, care, safety and routine maintenance of IRIDEX lasers and delivery devices that will allow the attendees to train other office staff, and help ensure properly operating equipment.

TECHNICAL TRAINING SEMINARS (2 - 3 DAY SEMINARS) These seminars are designed for BioMed engineers and other technical individuals. They will cover technical troubleshooting, basic repair, and routine maintenance of IRIDEX laser products and delivery devices. For more information, dates and fees, contact: Ahmad Zadeh at (800) 388-9087, ext. 3060 (USA); 650-962-8848, ext. 3060 (Outside of USA); azadeh@iridex.com; or return the enclosed business reply card.

Did you Know?

A NEW CEO ON BOARD On July 5, 2005, IRIDEX’ Board of Directors appointed Barry Caldwell as its new President and CEO. Ted Boutacoff, who has served as President and CEO since 1989, has been elected to the position of Chairman of the Board.

Barry has more than 30 years of general management, sales, marketing and corporate business development experience in the ophthalmic industry and has managed medical device, pharmaceutical and consumer-related products. He brings to IRIDEX a strong history of execution and an incredible body of knowledge, relationships, and experience in the ophthalmic industry. For more information, see the July 5, 2005 press release at www.iridex.com.

U.S. MARKET
We are pleased to announce the appointment of Robin Drawdy as the Area Sales Manager for the Southeastern U.S. Robin has extensive experience in ophthalmology including assignments with Allergan, and most recently, with Laser Diagnostic Technologies. Robin is based in Atlanta, GA. We are also pleased to welcome Jeff Zeilinger as the Area Sales Manager for the Mid-Atlantic states. Jeff joins us after 7 years with Heine USA. Jeff is based in Allentown,PA.

LATIN AMERICA AND CARIBBEAN MARKETS
We are pleased to share the changes that have occurred in our distribution channels in Latin America. Since attending the Pan American Congress in Santiago, Chile in March 2005, we have appointed 8 new distributors in Chile, Brazil, Bolivia, Argentina, Venezuela, Peru, Dominican Republic, and Mexico. We have also increased our technical service, sales, and market coverage by the addition of Mr. Gustavo Brescia as Field Service Engineer, International, who is based in Buenos Aires, Argentina; and Mr. Guillermo Molina as Area Sales Manager, Latin America, who is based in Miami, FL. These positions were created to provide direct support to the newly appointed distributors in Mexico, Central and South America, and the Caribbean. Both gentlemen have extensive experience in the ophthalmic laser business.

CANADIAN MARKET
We are pleased to announce that Pacific Medical has been appointed IRIDEX’ distributor for the Canadian market. Previously, Pacific Medical was responsible for IRIS Medical products in Western Canada. Their rapid expansion to cover Canada opened this opportunity for IRIDEX’ products to be supported by an excellent organization.

JOINT LICENSING AGREEMENT IRIDEX and Innovatech Surgical have signed a joint licensing agreement for endophotocoagulation probes. This agreement gives IRIDEX options for worldwide distribution rights to Innovatech’s current and future disposable endo ocular probes and Innovatech will license IRIDEX’ proprietary probe/laser connector. This alliance will expand IRIDEX’ consumable product line and provide a wider array of laser probe options to satisfy the demands of vitreoretinal surgeons worldwide. For more information, see the July 12, 2005 press release at www.iridex.com.

WORLD HEALTH ORGANIZATION In 2004, IRIDEX participated in the World Health Organization’s (W.H.O.) Elimination of Preventable Child Blindness Project. This five-year project, started by W.H.O. in 2002, focuses on training of health personnel for prevention, early detection and treatment; and establishes child-friendly “Centres for Sight of Children” in 30 countries. In support of this project, IRIDEX placed multiple OcuLight lasers (810 nm) and laser indirect ophthalmoloscopes in numerous countries worldwide, including Ethiopia, Lithuania, Romania, Malaysia, Morocco, Philippines, Indonesia, and Latin America. We are pleased that W.H.O. selected the IRIS Medical laser systems in support of their efforts to achieve global elimination of avoidable blindness in children. The OcuLight is well-established worldwide as the laser of choice for the treatment of retinopathy of prematurity (ROP).

PARENTS’ GUIDE TO ROP IRIDEX partnered with the Association for Retinopathy of Prematurity and Related Diseases (ROPARD) to published a parent education brochure on understanding ROP. Tis brochure is available in English and Spanish and can be ordered directly through ROPARD at www.ropard.org.
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